Varivax

Generic Name: varicella virus (chickenpox) vaccine (VAR i SEL a VYE rus vax EEN)

Brand Names: Varivax

What is varicella virus vaccine?

Varicella (commonly known as chickenpox) is a common childhood disease that causes fever, skin rash, and a breakout of fluid-filled blisters on the skin. Most people who receive this vaccine will not get chickenpox, or will get only a mild case and will recover faster.

Chickenpox is usually mild, but it can be serious or even fatal in young infants and in adults. It can lead to severe skin infection, breathing problems, brain damage, or death. A person who has had chickenpox can develop herpes zoster (also called shingles) later in life, which causes severe nerve pain, and hearing or vision problems, which may last for months or years.

Chickenpox is spread from person to person through the air, or by coming into contact with the fluid from a chickenpox blister.

Varicella virus vaccine is for use in adults and children who are at least 12 months old.

This vaccine works by exposing you to a small dose of the virus or a protein from the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Like any vaccine, the varicella virus vaccine may not provide protection from disease in every person.

What is the most important information I should know about this vaccine?

The varicella vaccine is given in a series of shots. The first shot is usually given to a child who is 12 to 15 months old. The booster shot is then given at 4 to 6 years of age, or at least 3 months after the first dose.

If you are at least 13 years old and you have never had chickenpox or received this vaccine, you should receive two varicella virus vaccines at least 28 days apart.

Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Do not give salicylates such as aspirin, Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others to a child under 18 for at least 6 weeks after he or she has received varicella vaccine. A serious condition called Reye's Syndrome has been reported in young people with chickenpox who take aspirin or salicylates.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with chickenpox is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

What should I discuss with my healthcare provider before receiving this vaccine?

You should not receive this vaccine if you are allergic to gelatin, neomycin (Mycifradin, Neo-Fradin, Neo-Tab), or if you have ever had a life-threatening allergic reaction to any vaccine containing varicella.

You should also not receive this vaccine if you have:

• 
  

  active tuberculosis infection that is not being treated;

  
  


• 
  

  a history of Guillain-Barré syndrome;

  
  


• 
  

  a chronic disease such as asthma or other breathing disorder, diabetes, kidney disease, or blood cell disorder such as anemia;

  
  


• 
  

  if you or someone in your household has severe immune suppression caused by disease (such as cancer, HIV, or AIDS), or by receiving certain medicines such as steroids, chemotherapy or radiation;

  
  


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  if you are under 18 years old and have recently taken aspirin or other similar medicines such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others;

  
  


• 
  

  if you have recently received a stem cell transplant; or

  
  


• 
  

  if you are pregnant.

  
  

Before receiving varicella virus (Chickenpox) vaccine, talk to your doctor if you have:

• 
  

  thrombocytopenia purpura (easy bruising or bleeding);

  
  


• 
  

  active tuberculosis infection; or

  
  


• 
  

  if you have received an immune globulin or other blood product within the past year.

  
  

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Avoid becoming pregnant for at least 3 months after receiving a varicella vaccine. Do not receive this vaccine without telling your doctor if you are breast-feeding a baby.

How is this vaccine given?

This vaccine is given as an injection (shot) under the skin. You will receive this injection in a doctor's office or other clinic setting.

The varicella vaccine is given in a series of shots. The first shot is usually given to a child who is 12 to 15 months old. The booster shot is then given at 4 to 6 years of age, or at least 3 months after the first dose.

If you are at least 13 years old and you have never had chickenpox or received this vaccine, you should receive two varicella virus vaccines at least 28 days apart.

Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to take.

It is especially important to prevent fever from occurring if you have a seizure disorder such as epilepsy.

This vaccine can cause false results on a skin test for tuberculosis. Tell any doctor who treats you if you have received a varicella virus vaccine within the past 4 to 6 weeks.

What happens if I miss a dose?

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine?

For at least 6 weeks after receiving a varicella vaccine, avoid coming into contact with newborn infants, pregnant women who have never had chickenpox, and anyone who has a weak immune system. There is a chance that you could pass the virus to a person with a weak immune system or no immunity to chickenpox.

This vaccine side effects

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with chickenpox is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• 
  

  cough, tight feeling in your chest, breathing problems;

  
  


• 
  

  seizure (black-out or convulsions);

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  behavior changes; or

  
  


• 
  

  high fever (within a few hours or a few weeks after the vaccine).

  
  

Less serious side effects include:

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  redness, pain, or swelling where the shot was given;

  
  


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  low fever;

  
  


• 
  

  mild skin rash;

  
  


• 
  

  runny or stuffy nose, cough, sore throat;

  
  


• 
  

  headache, tired feeling;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  joint or muscle pain; or

  
  


• 
  

  nausea, vomiting, stomach pain, diarrhea.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What other drugs will affect varicella virus vaccine?

Do not use salicylates (aspirin or aspirin containing products) for at least six weeks after receiving the vaccine. A serious condition called Reye's Syndrome has been reported in patients with chicken pox taking salicylates.

Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

• 
  

  an oral, nasal, inhaled, or injectable steroid medicine;

  
  


• 
  

  medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or

  
  


• 
  

  medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

  
  

If you are using any of these medications, you may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

There may be other drugs that can affect this vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Varivax resources

• Varivax Side Effects (in more detail)
• Varivax Use in Pregnancy & Breastfeeding
• Varivax Drug Interactions
• Varivax Support Group
• 0 Reviews for Varivax - Add your own review/rating

• Varivax Prescribing Information (FDA)


• Varivax Monograph (AHFS DI)


• Varivax Advanced Consumer (Micromedex) - Includes Dosage Information


• Varivax MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Varivax with other medications

• Varicella-Zoster, Prophylaxis

Where can I get more information?

• Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

See also: Varivax side effects (in more detail)

Made

FULL PRESCRIBING INFORMATION

BOXED WARNING WARNING – Skin disinfection is required before and after application

1. INDICATIONS AND USAGE

1.1.    Treatment of face  and neck wrinkles

1.2.    Skin tone improvement

1.3.    Local treatment of skin aging

1.4.    Stimulation of connective tissue metabolism.

Standard  protocol consists of one session a week for 5-7 weeks. For prolonged treatments, 2 sessions for the first week, 1 session a week for 1 month and then 1 session a month are recommended.

2. DOSAGE AND ADMINISTRATION

2.1.    Treatment of skin tone improvement for IM administration:  1 vial 1-3 times a week according to severity and clinical evolution

2.2.    Treatment of skin tone improvement and  Treatment of  face and neck wrinkles using mesotherapy technique:  1 vial. Using a 4 mm, 30G needle, make the classic intradermal injections utilizing mesotherapy technique.

2.3.    Treatment of face and neck wrinkles using mesotherapy technique: 0.3 ml per wrinkle/cannulation. Using a 13 mm, 30G needle, insert the needle beneath the skin the full length of the needle, cannulate the wrinkle by moving the needle gently to left and right, while injecting the content of the syringe (tunnelling technique) as the needle is withdrawn.

2.4.    Standard  protocol according to mesotherapy technique consists of one session a week for 5-7 weeks. For prolonged treatments, 2 sessions for the first week, 1 session a week for 1 month and then 1 session a month are recommended.

2.5.    Opening of Vials: Use sterile needles and sterile syringe. Do not reuse. Do not use if foreign particles are present. Draw 1 cc of air into syringe, insert needle into vial inject air and withdraw the solution into the syringe.

3. DOSAGE FORMS AND STRENGTHS

3.1.    Injectable solution for subcutaneneous, intradermal, or intramuscular  administration. Forms: 2 ml glass vials

3.2.    Each ingredient is attenuated according to the procedures stated in the Homeopathic Pharmacopeia of United States.

Active ingredients: a-Ketoglutaricum acidum 6X; Ascorbic acid 6X; Barium oxalosuccinate 6X; Calcarea fluorica 30X;  Cis- Aconitic acid 6X; Collagen 8X; Collagen 30X; Fumaricum acidum 6X; Funiculus umbilicalis 10X; Funiculus umbilicalis 30X; Galium aparine 6X; Glandula suprarenalis 10X; Hepar  10X; Hyaluronidase 8X; Hyaluronidase 30X; Magnesium gluconate 6X; Manganum phosphoricum 10X; Mercurius solubilis 20X; Muscle tissue 20X; Natrum oxalaceticum 6X; Natrum pyruvicum 8X; Nicotinamidum 6X;  Placenta 10X; Pyridoxinum hydrochloricum 6X; Riboflavinum 6X; Skin tissue 8X; Skin tissue 30X; Sulphur 12X; Thiaminum hydrochloricum 6X; Thuja occidentalis 6X.

Inactive ingredient: Sterile isotonic sodium chloride solution.

4. CONTRAINDICATIONS

4.1.    None Known

5. WARNINGS AND PRECAUTIONS

5.1.    Be sure to disinfect the area before application. After treatment, avoid alcohol containing disinfectants as they produce local irritation that appears unpleasant on face. In most cases, the slight irritation disappears within 2 hours.

5.2.    Skin cleansing/disinfection is required before application. Saprophytic bacteria may produce injection site abscesses with improper skin preparation.

6. ADVERSE REACTIONS

6.1.    The most common mild adverse reaction is slight reddening at the injection site due to the mechanical effect of the needle or a superficial skin reaction of mild erythema.

7. DRUG INTERACTIONS

7.1.None

8. USE IN SPECIFIC POPULATIONS

8.1    No restriction.

9. DRUG ABUSE AND DEPENDENCE

9.1.    No Known

10. OVERDOSAGE

10.1.    No Known

11. DESCRIPTION

Made® is a sterile solution Made with isotonic sodium chloride solution.

It is a homeopathic complex medicine and its active ingredients may be classified in 3 groups according to the starting material:

11.1.    Herbal and mineral remedies

11.2.    Enzymes and intermediates of the Krebs cycle

11.3.    Biological substrates.

The strengths of the homeopathic ingredients  are related to their physiological function,  as follows:

•    The attenuation of the herbal and mineral remedies have been selected in order to act as a detoxifier of the skin matrix

•    Enzymes and intermediates of the Krebs cycle at low attenuations stimulate the physiological mechanism of the cell respiration cycle.

•    The attenuation of the biological substrates act to target the organs and as supporters of the endogenous production of the structural components of skin tissue.

Made® shows a “flattening” effect on wrinkles, this improves as the protocol is continued; the effect  is   due  to improved metabolism in the  area of application not due to a filler effect.

12. CLINICAL PHARMACOLOGY

12.1.    Mechanism of Action

The medication acts through   a low-dose enzymatic mechanism. Due to the homeopathic nature of the active ingredients, receptors are not blocked due to saturation of their active sites, rather there is a feed back regulation of the physiological metabolism of collagen. As enzymes may be easily blocked due to different events (on-going diseases, aging, sun exposure, etc.) homeopathic dilutions of enzymatic substrates act as enzyme inducing tools.

12.2.    Pharmacodynamics

The physiological effects of Made® is  due to  the effects of the ingredients, according to their description in the Homeopathic Materia Medica.

In homeopathy there is no direct relationship between dose and effect, rather  there is a relationship between attenuation and balancing effect on biochemical pathways.

In Made® the attenuation of each ingredient has been selected in order to promote the biochemical pathways of collagen synthesis.

12.3.    Pharmacokinetics

The homeopathic attenuation  provides complete bioavability of the active ingredients. 

13. NONCLINICAL TOXICOLOGY

13.1.    Made® has no level of toxicity due to the attenuation of the ingredients.

14. CLINICAL STUDIES

14.1.    One post-approval cohort clinical study has been performed according to the GCP. (1)

The study included 681 patients of both genders (578 female – 103 male) aged between 35 and 75 (female) and between 40 and 70 (male) without exclusion criteria and lasted 5 years from 1998 to 2003.

3.8% of the patients dropped out of the study for reasons that were not connected with the treatment.

The application consisted of linear infiltration of the wrinkle, utilizing  mesotherapy technique, or infiltration inside the wrinkle, utilizing the tunnelization technique.

Treatment consisted of 8 sessions on a weekly basis, then for some patients the treatment was continued as one session a month for 2-3 months.

The results were evaluated before and after the program via the subjective classification of the visual and tactile characteristics of the wrinkles and the slackening of the face and neck tissues.

Mild reactions to the treatment were only observed in 20 cases (3%) with slight erythema at the injection site, which disappeared after a few minutes.

Made®  proved to be highly effective with high levels of tolerability for all types of wrinkles and skin relaxation.

The best results were observed in female patients between 30-40 and 40-50 years old.

15. REFERENCES

(1)    M. De Bellis : Treatment of wrinkles and skin slackening using the intradermal injection of a complex homeopathic remedy. Results of an observation study on 681 patients. La Medicina Biologica, 2004/2; 7-18.

- H.H. Reckeweg : Materia medica omeopatica. Ed. 1. Guna editore.

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1.    NDC 17089-238-31  10 glass vials packed in carton box

16.2.    NDC 17089-238-32  50 glass vials packed in carton box

17. PATIENT COUNSELING INFORMATION

17.1.    Patients should be informed of the homeopathic approach and the Made® therapeutic goal. Made® supports  homologous collagen metabolism without  a direct filling effect.

PACKAGE LABEL

Made  .alpha.-ketoglutaric acid - aconitic acid, cis - ascorbic acid - barium cation - calcium fluoride - fumaric acid - galium aparine - hyaluronidase - magnesium gluconate - manganese phosphate, dibasic - mercury - niacinamide - pork - pork liver - pyridoxine hydrochloride - riboflavin - sodium diethyl oxalacetate - sodium pyruvate - sulfur - sus scrofa adrenal gland - sus scrofa collagen - sus scrofa placenta - sus scrofa skin - sus scrofa umbilical cord - thiamine hydrochloride - thuja occidentalis twig -   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 17089-238 Route of Administration INTRADERMAL, SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength .ALPHA.-KETOGLUTARIC ACID (.ALPHA.-KETOGLUTARIC ACID) .ALPHA.-KETOGLUTARIC ACID 6 [hp_X]  in 2 mL ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 6 [hp_X]  in 2 mL BARIUM OXALOSUCCINATE (BARIUM OXALOSUCCINATE) BARIUM OXALOSUCCINATE 6 [hp_X]  in 2 mL CALCIUM FLUORIDE (CALCIUM FLUORIDE) CALCIUM FLUORIDE 30 [hp_X]  in 2 mL ACONITIC ACID, CIS- (ACONITIC ACID, CIS-) ACONITIC ACID, CIS- 6 [hp_X]  in 2 mL SUS SCROFA COLLAGEN (SUS SCROFA COLLAGEN) SUS SCROFA COLLAGEN 8 [hp_X]  in 2 mL FUMARIC ACID (FUMARIC ACID) FUMARIC ACID 6 [hp_X]  in 2 mL SUS SCROFA UMBILICAL CORD (SUS SCROFA UMBILICAL CORD) SUS SCROFA UMBILICAL CORD 10 [hp_X]  in 2 mL GALIUM APARINE (GALIUM APARINE) GALIUM APARINE 6 [hp_X]  in 2 mL SUS SCROFA ADRENAL GLAND (SUS SCROFA ADRENAL GLAND) SUS SCROFA ADRENAL GLAND 10 [hp_X]  in 2 mL PORK LIVER (PORK LIVER) PORK LIVER 10 [hp_X]  in 2 mL HYALURONIDASE (HYALURONIDASE) HYALURONIDASE 8 [hp_X]  in 2 mL MAGNESIUM GLUCONATE (MAGNESIUM CATION) MAGNESIUM GLUCONATE 6 [hp_X]  in 2 mL MANGANESE PHOSPHATE, DIBASIC (MANGANESE PHOSPHATE, DIBASIC) MANGANESE PHOSPHATE, DIBASIC 10 [hp_X]  in 2 mL MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS 20 [hp_X]  in 2 mL PORK (PORK) PORK 20 [hp_X]  in 2 mL SODIUM DIETHYL OXALACETATE (DIETHYL OXALACETATE) SODIUM DIETHYL OXALACETATE 6 [hp_X]  in 2 mL SODIUM PYRUVATE (PYRUVIC ACID) SODIUM PYRUVATE 8 [hp_X]  in 2 mL NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 6 [hp_X]  in 2 mL SUS SCROFA PLACENTA (SUS SCROFA PLACENTA) SUS SCROFA PLACENTA 10 [hp_X]  in 2 mL PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 6 [hp_X]  in 2 mL RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 6 [hp_X]  in 2 mL SUS SCROFA SKIN (SUS SCROFA SKIN) SUS SCROFA SKIN 8 [hp_X]  in 2 mL SULFUR (SULFUR) SULFUR 12 [hp_X]  in 2 mL THIAMINE HYDROCHLORIDE (THIAMINE) THIAMINE HYDROCHLORIDE 6 [hp_X]  in 2 mL THUJA OCCIDENTALIS TWIG (THUJA OCCIDENTALIS TWIG) THUJA OCCIDENTALIS TWIG 6 [hp_X]  in 2 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.018 mL  in 2 mL WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 17089-238-31 10 VIAL In 1 BOX contains a VIAL, GLASS 1 2 mL In 1 VIAL, GLASS This package is contained within the BOX (17089-238-31) 2 17089-238-32 50 VIAL In 1 BOX contains a VIAL, GLASS 2 2 mL In 1 VIAL, GLASS This package is contained within the BOX (17089-238-32)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/29/2006

Labeler - Guna spa (430538264)

Establishment
Name	Address	ID/FEI	Operations
Guna spa		430538264	manufacture

Revised: 05/2010Guna spa

Malathion

Malathion Lotion USP, 0.5%

Rx Only

For topical use only. Not for oral or ophthalmic use.

Malathion Description

Malathion lotion contains 0.005 g of Malathion per mL in a vehicle of isopropyl alcohol (78%), terpineol, dipentene, and pine needle oil. The chemical name of Malathion is (±) - [(dimethoxyphosphinothioyl) - thio] butanedioic acid diethyl ester. Malathion has a molecular weight of 330.36, represented by C10H19O6PS2, and has the following chemical structure:

Malathion - Clinical Pharmacology

Malathion is an organophosphate agent which acts as a pediculicide by inhibiting cholinesterase activity in vivo. Inadvertent transdermal absorption of Malathion has occurred from its agricultural use. In such cases, acute toxicity was manifested by excessive cholinergic activity, i.e., increased sweating, salivary and gastric secretion, gastrointestinal and uterine motility, and bradycardia (see OVERDOSAGE). Because the potential for transdermal absorption of Malathion from Malathion lotion is not known at this time, strict adherence to the dosing instructions regarding its use in children, method of application, duration of exposure, and frequency of application is required.

Indications and Usage for Malathion

Malathion lotion is indicated for patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair.

Contraindications

Malathion lotion is contraindicated for neonates and infants because their scalps are more permeable and may have increased absorption of Malathion. Malathion lotion should also not be used on individuals known to be sensitive to Malathion or any of the ingredients in the vehicle.

Warnings

1. Malathion lotion is flammable. The lotion and wet hair should not be exposed to open flames or electric heat sources, including hair dryers and electric curlers. Do not smoke while applying lotion or while hair is wet.
   
   Allow hair to dry naturally and to remain uncovered after application of Malathion lotion.


2. Malathion lotion should only be used on children under the direct supervision of an adult.


3. If Malathion lotion comes into contact with the eyes, flush immediately with water. Consult a physician if eye irritation persists.


4. If skin irritation occurs, discontinue use of product until irritation clears. Reapply the Malathion lotion, and if irritation reoccurs, consult a physician.


5. Chemical burns including second-degree burns and stinging sensations may occur with the use of Malathion lotion.

General

Keep out of reach of children. Close eyes tightly during product application. If accidentally placed in the eye, flush immediately with water. Use only on scalp hair.

Information to Patients

1. Malathion lotion is flammable. The lotion and hair wet with lotion should not be exposed to open flames or electric heat sources, including hair dryers and electric curlers. Do not smoke while applying lotion or while hair is wet.
   
   The person applying Malathion lotion should wash hands after application. Allow hair to dry naturally and to remain uncovered after application of Malathion lotion.


2. Malathion lotion should only be used on children under the direct supervision of an adult. Children should be warned to stay away from lighted cigarettes, open flames, and electric heat sources while the hair is wet.


3. In case of accidental ingestion of Malathion lotion by mouth, seek medical attention immediately.


4. If you are pregnant or nursing, you should contact your physician before using Malathion lotion.


5. If Malathion lotion comes into contact with the eyes, flush immediately with water. Consult a physician if eye irritation persists or if visual changes occur.


6. If skin irritation occurs, wash scalp and hair immediately. If the irritation clears, Malathion lotion may be reapplied. If irritation reoccurs, consult a physician.


7. Burns and stinging sensations may occur when using Malathion lotion.


8. Apply Malathion lotion on the scalp hair in an amount just sufficient to thoroughly wet hair and scalp. Pay particular attention to the back of the head and neck when applying Malathion lotion. Anyone applying Malathion lotion should wash hands immediately after the application process is complete.


9. Allow hair to dry naturally and to remain uncovered. Shampoo hair after 8 to 12 hours, again paying attention to the back of the head and neck while shampooing.


10. Rinse hair and use a fine - toothed (nit) comb to remove dead lice and eggs.


11. If lice are still present after 7 - 9 days, repeat with a second application of Malathion lotion.


12. Further treatment is generally not necessary. Other family members should be evaluated by a physician to determine if infested, and if so, receive treatment.

Laboratory Tests

There are no special laboratory tests needed in order to use this medication.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Carcinogenesis, mutagenesis and impairment of fertility have not been studied with Malathion lotion (0.5% pharmaceutical grade Malathion). However, following long-term oral administration of technical grade Malathion to rodents via dietary supplementation, increased incidences of hepatocellular neoplastic lesions were observed in B6C3F1 mice dosed for 18 months at Malathion doses greater than 1500 mg/kg/day, and in female F344 rats dosed for 2 years at Malathion doses greater than 400 mg/kg/day. These tumors occurred only in association with severe hepatic toxicity and chronic suppression of acetylcholinesterase activity, or at doses causing excessive mortality. Based on body surface area, doses at which carcinogenic effects were observed in rodents following life-time exposures to Malathion were approximately 14- to 26-fold greater than the maximum dose anticipated in a 10 kg child following a single use of Malathion lotion, assuming 100% bioavailability. Actual systemic exposures are expected to be less than 10% of the administered dose.

The Malathion of greater than pharmaceutical-grade purity used in Malathion lotion has not been tested for genotoxicity. The technical-grade Malathion (95% pure) was found to be negative in Salmonella typhimurium, equivocally positive in the mouse lymphoma cell assay, 577 and positive in in vitro chromosomal aberration and sister chromatid exchange assays. Fifteen separate in vitro gene mutation studies with Malathion of unknown purity have reported negative results, while three studies reported Malathion to be mutagenic in bacterial cells. Both technical grade (94–96.5%) and purified (98-99%) Malathion have been reported to cause chromosomal aberrations and sister chromatid exchanges in vitro in human and hamster cell lines. In vivo chromosomal aberration and micronucleus studies of technical-grade Malathion are reported to be positive, whereas an in vivo chromosomal aberration study of >99% pure Malathion was reported to be negative. Furthermore, mice exposed to Malathion in their drinking water for 7 weeks demonstrated no evidence of chromosome damage in bone marrow cells, spermatogonia, or primary spermatocytes. Lack of details makes independent evaluation of the results of these assays impossible. Ashby and Purchase have suggested that impurities may be responsible for some of the observed genetic activity of Malathion.

Reproduction studies performed with Malathion in rats at doses over 180 fold greater than those anticipated in a 60 kg adult (based on body surface area and assuming 100% bioavailability) revealed no evidence of impaired fertility.

Pregnancy

Pregnancy Category B

There was no evidence of teratogenicity in studies in rats and rabbits at doses up to 900 mg/kg/day and 100 mg/kg/day Malathion, respectively. A study in rats failed to show any gross fetal abnormalities attributable to feeding Malathion up to 2,500 ppm (~ 200 mg/kg/day) in the diet during a three - generation evaluation period. These doses were approximately 40 to 180 times higher than the dose anticipated in a 60 kg adult (based on body surface area and assuming 100% bioavailability). Because animal reproduction studies are not always predictive of human responses, this drug should be used (or handled) during pregnancy only if clearly needed.

Nursing Mothers

Malathion in an acetone vehicle has been reported to be absorbed through human skin to the extent of 8% of the applied dose. However, percutaneous absorption from the Malathion lotion, 0.5% formulation has not been studied, and it is not known whether Malathion is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Malathion lotion is administered to (or handled by) a nursing mother.

Pediatric Use

The safety and effectiveness of Malathion lotion in children less than 6 years of age has not been established via well-controlled trials.

Adverse Reactions

Malathion has been shown to be irritating to the skin and scalp. Other adverse reactions reported are chemical burns including second-degree burns. Accidental contact with the eyes can result in mild conjunctivitis.

It is not known if Malathion lotion has the potential to cause contact allergic sensitization.

Overdosage

Consideration should be given, as part of the treatment program, to the high concentration of isopropyl alcohol in the vehicle.

Malathion, although a weaker cholinesterase inhibitor than some other organophosphates, may be expected to exhibit the same symptoms of cholinesterase depletion after accidental ingestion orally. If accidentally swallowed, vomiting should be induced promptly or the stomach lavaged with 5% sodium bicarbonate solution.

Severe respiratory distress is the major and most serious symptom of organophosphate poisoning requiring artificial respiration, and atropine may be needed to counteract the symptoms of cholinesterase depletion.

Repeat analyses of serum and RBC cholinesterase may assist in establishing the diagnosis and formulating a long - range prognosis.

Malathion Dosage and Administration

1. Apply Malathion lotion on DRY hair in amount just sufficient to thoroughly wet the hair and scalp. Pay particular attention to the back of the head and neck while applying Malathion lotion. Wash hands after applying to scalp.


2. Allow hair to dry naturally - use no electric heat source, and allow hair to remain uncovered.


3. After 8 to 12 hours, the hair should be shampooed.


4. Rinse and use a fine - toothed (nit) comb to remove dead lice and eggs.


5. If lice are still present after 7 - 9 days, repeat with a second application of Malathion lotion.

Further treatment is generally not necessary. Other family members should be evaluated by a physician to determine if infested, and if so, receive treatment.

Clinical Studies

Two controlled clinical trials evaluated the pediculicidal activity of Malathion lotion. Patients applied the lotion to the hair and scalp in quantities, up to a maximum of 2 fl. oz., sufficient to thoroughly wet the hair and scalp. The lotion was allowed to air dry and was shampooed with Prell shampoo 8 to 12 hours after application. Patients in both the Malathion lotion group and in the vehicle group were examined immediately after shampooing, 24 hours after, and 7 days after for the presence of live lice. Results are shown in the following table:

Number of Patients Without Live Scalp Lice

Treatment	Immediately After	24 Hrs. After	7 Days After
Malathion lotion	129/129	122/129	114/126
Malathion vehicle	105/105	63/105	31/105

The presence or absence of ova at day 7 was not evaluated in these studies. The presence or absence of live lice or ova at 14 days following treatment was not evaluated in these studies. The residual amount of Malathion on hair and scalp is unknown.

How is Malathion Supplied

Malathion Lotion USP, 0.5%, is supplied in bottles of 2 fl. oz. (59 mL) NDC 51672-5277-4. Store at controlled room temperature 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].

Flammable. Keep away from heat and open flame.

Mfd. by:	Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 26110
Dist. by:	Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

Issued: January, 2012

70829-0112-1  577

PRINCIPAL DISPLAY PANEL - 59 mL Bottle Carton

2 fl oz (59 mL)

NDC 51672-5277-4

Malathion

Lotion

USP, 0.5%

In isopropyl alcohol (78%),

terpineol, dipentene and

pine needle oil.

PEDICULICIDE/OVICIDE

WARNING:

Contains flammable alcohol.

Avoid smoking, open flame and hair dryers.

Allow hair to dry naturally and uncovered.

Rx only

TARO

Malathion  Malathion  lotion

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51672-5277 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Malathion (Malathion) Malathion 0.005 g  in 1 mL

Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL   TERPINEOL   LIMONENE, (+/-)-   PINE NEEDLE OIL (PINUS SYLVESTRIS)

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51672-5277-4 1 BOTTLE In 1 CARTON contains a BOTTLE 1 59 mL In 1 BOTTLE This package is contained within the CARTON (51672-5277-4)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018613	08/02/2009

Labeler - TARO PHARMACEUTICALS U.S.A., INC. (145186370)

Establishment
Name	Address	ID/FEI	Operations
TARO PHARMACEUTICAL INDUSTRIES LTD.		600072078	MANUFACTURE

Revised: 02/2012TARO PHARMACEUTICALS U.S.A., INC.

Magnesium chloride

Generic Name: magnesium chloride (mag NEE see um KLOE ride)

Brand names: Mag 64, Mag-Delay, Mag-SR, Slow-Mag, Chloromag

What is magnesium chloride?

Magnesium is a mineral that occurs naturally in the body and is found in certain foods. Magnesium is important for many systems in the body especially the muscles, nerves, heart, and bones.

Magnesium chloride is used to treat or prevent magnesium deficiency (lack of natural magnesium in the body).

Magnesium chloride may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about magnesium chloride?

You should not use this medication if you are allergic to it, or if you have kidney disease, a stomach ulcer or disorder, or if you are dehydrated.

Before taking magnesium chloride, tell your doctor if you have any other medical conditions or any type of allergy.

Tell your doctor if you are pregnant or breast-feeding. It is not known whether magnesium chloride could harm an unborn baby, or if it passes into breast milk and could harm a nursing baby. Your dose needs may be different while you are pregnant or breast-feeding.

Avoid using antacids or laxatives without your doctor's advice. These medications may contain minerals and if you take certain products together you may get too much magnesium.

Tell your doctor about all other medications you use, especially antibiotics, ADHD medication, thyroid medication, or medication for osteoporosis or Paget's disease.

Magnesium chloride is only part of a complete program of treatment that may also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor.

To be sure this medication is helping your condition and not causing harmful effects, your blood may need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any follow-up visits to your doctor.

Call your doctor at once if you have signs of too much magnesium in your blood, such as depression, feeling tired or irritable, muscle cramps, or severe or ongoing diarrhea.

What should I discuss with my healthcare provider before taking magnesium chloride?

You should not use this medication if you are allergic to it, or if you have:

• kidney disease;


• 
  

  a stomach ulcer or disorder; or

  
  


• 
  

  if you are dehydrated.

  
  

Before taking magnesium chloride, tell your doctor if you have any other medical conditions or any type of allergy.

It is not known whether magnesium chloride is harmful to an unborn baby. Your dose needs may be different during pregnancy. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether magnesium chloride passes into breast milk or if it could harm a nursing baby. Your dose needs may be different while you are nursing. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take magnesium chloride?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Take this medication with a full glass of water. Magnesium chloride should be taken with food if it upsets your stomach or causes diarrhea. Follow your doctor's instructions. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.

It is important to use magnesium chloride regularly to get the most benefit. Try to take your dose(s) at the same time each day.

Magnesium chloride is only part of a complete program of treatment that may also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat to help control your condition.

To be sure this medication is helping your condition and not causing harmful effects, your blood may need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any follow-up visits to your doctor.

Store magnesium chloride at room temperature away from moisture, heat, and light.

See also: Magnesium chloride dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include thirst, confusion, severe drowsiness, slow heart rate, urinating less than usual or not at all, swelling, weight gain, feeling short of breath, or fainting.

What should I avoid while taking magnesium chloride?

Avoid using antacids or laxatives without your doctor's advice. Use only the specific type of antacid your doctor recommends. These medications may contain minerals and if you take certain products together you may get too much magnesium.

If you are taking a tetracycline antibiotic, avoid taking it within 2 hours before or 3 hours after you take magnesium chloride. Tetracycline antibiotics include doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap, and others).

Magnesium chloride side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe dizziness, difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have signs that you magnesium blood levels are too low, such as:

• 
  

  depression, feeling tired or irritable;

  
  


• 
  

  muscle cramps; or

  
  


• 
  

  severe or ongoing diarrhea.

  
  

Less serious side effects may include:

• 
  

  mild diarrhea;

  
  


• 
  

  nausea, stomach pain; or

  
  


• 
  

  upset stomach.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Magnesium chloride Dosing Information

Usual Adult Dose for Hypomagnesemia:

Mild hypomagnesemia:
If oral administration is tolerated, mild hypomagnesemia may be treated with Slow-Mag 1 tablet (535 mg magnesium chloride, 64 mg elemental magnesium) orally once a day.

Severe hypomagnesemia:
40 mEq (4 g magnesium chloride) in 5% dextrose or normal saline by IV infusion once over 3 hours.

Usual Adult Dose for Myocardial Infarction:

10 mEq in 5% dextrose or normal saline by IV infusion once within the first 24 hours of infarction.

Usual Pediatric Dose for Hypomagnesemia:

Neonatal:
Hypomagnesemia: IV: Magnesium chloride: 0.2 to 0.4 mEq/kg/dose every 8 to 12 hours for 2 to 3 doses
Daily maintenance magnesium: IV: Magnesium chloride: 0.25 to 0.5 mEq/kg/day

Children:
IM or IV: Magnesium chloride: 0.2 to 0.4 mEq/kg/dose every 4 to 6 hours for 3 to 4 doses; maximum single dose: 16 mEq
Oral: Note: Achieving optimal magnesium levels using oral therapy may be difficult due to the propensity for magnesium to cause diarrhea; IV replacement may be more appropriate particularly in situations of severe deficit: Magnesium chloride: 10 to 20 mg/kg elemental magnesium per dose up to 4 times/day

Daily maintenance magnesium: IV Magnesium chloride:
Infants and Children less than or equal to 45 kg: 0.25 to 0.5 mEq/kg/day
Adolescents greater than 45 kg and Adults: 0.2 to 0.5 mEq/kg/day or 3 to 10 mEq/1000 kcal/day (maximum: 8 to 20 mEq/day).

What other drugs will affect magnesium chloride?

Tell your doctor about all other medications you use, especially:

• 
  

  digoxin (Lanoxin, Lanoxicaps);

  
  


• 
  

  sodium polystyrene sulfonate (Kalexate, Kayexalate, Kionex);

  
  


• 
  

  an amphetamine such as ADHD medication (Adderall, Vyvanse, Dexedrine, and others);

  
  


• 
  

  an antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), and others;

  
  


• 
  

  medication for osteoporosis or Paget's disease, such as alendronate (Fosamax), ibandronate (Boniva), etidronate (Didronel), pamidronate (Aredia), or risedronate (Actonel); or

  
  


• 
  

  thyroid replacement medication such as levothyroxine (Synthroid, Levothroid, Unithroid).

  
  

This list is not complete and there may be other drugs that can interact with magnesium chloride. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More magnesium chloride resources

• Magnesium chloride Side Effects (in more detail)
• Magnesium chloride Dosage
• Magnesium chloride Use in Pregnancy & Breastfeeding
• Magnesium chloride Drug Interactions
• Magnesium chloride Support Group
• 0 Reviews for Magnesium chloride - Add your own review/rating

• Magnesium Chloride Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Magnesium Chloride Professional Patient Advice (Wolters Kluwer)


• Chloromag Prescribing Information (FDA)

Compare magnesium chloride with other medications

• Heart Attack
• Hypomagnesemia

Where can I get more information?

• Your pharmacist can provide more information about magnesium chloride.

See also: magnesium chloride side effects (in more detail)

Valsartan/Hydrochlorothiazide

Pronunciation: val-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide
Generic Name: Valsartan/Hydrochlorothiazide
Brand Name: Diovan HCT

Valsartan/Hydrochlorothiazide may cause birth defects or fetal death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away.

Valsartan/Hydrochlorothiazide is used for:

Treating high blood pressure. It may also be used for other conditions as determined by your doctor.

Valsartan/Hydrochlorothiazide is an angiotensin II receptor blocker and diuretic combination. The angiotensin II receptor blocker works by relaxing the blood vessels. Exactly how the diuretic works to decrease blood pressure is not known, but it helps the kidneys to eliminate fluid and sodium from the body.

Do NOT use Valsartan/Hydrochlorothiazide if:

• you are allergic to any ingredient in Valsartan/Hydrochlorothiazide or to any other sulfonamide medicine (eg, sulfamethoxazole)


• you are pregnant


• you have severe kidney problems or are unable to urinate


• you are taking dofetilide or ketanserin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Valsartan/Hydrochlorothiazide:

Some medical conditions may interact with Valsartan/Hydrochlorothiazide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are able to become pregnant


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of angioedema (eg, swelling of the hands, face, lips, eyes, throat, or tongue; trouble swallowing or breathing; hoarseness), including angioedema caused by treatment with any other angiotensin II receptor blocker (eg, losartan) or an angiotensin converting enzyme (ACE) inhibitor (eg, captopril)


• if you are dehydrated; have low blood volume; have swelling or fluid retention; have severe diarrhea or vomiting; have low blood sodium, chloride, potassium, or magnesium levels; or have high blood calcium levels


• if you have asthma; gout; heart problems (eg, congestive heart failure); liver, gallbladder, or kidney problems; parathyroid gland problems; high blood cholesterol or lipid levels; or systemic lupus erythematosus


• if you have diabetes, especially if you are also taking aliskiren


• if you are on a low-salt (sodium) diet or you drink alcohol


• if you are on dialysis or you have recently had a certain type of nerve surgery (sympathectomy)


• if you take other medicines for high blood pressure or heart problems

Some MEDICINES MAY INTERACT with Valsartan/Hydrochlorothiazide. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Dofetilide or ketanserin because the risk of irregular heartbeat may be increased


• Aliskiren, potassium-sparing diuretics (eg, spironolactone), or potassium supplements because the risk of high blood potassium levels may be increased


• ACE inhibitors (eg, lisinopril) because the risk of kidney problems and high blood potassium levels may be increased


• Adrenocorticotropic hormone (ACTH), barbiturates (eg, phenobarbital), carbamazepine, corticosteroids (eg, prednisone), cyclosporine, diuretics (eg, furosemide), narcotic pain medicines (eg, morphine), rifampin, ritonavir, or other medicines for high blood pressure because they may increase the risk of Valsartan/Hydrochlorothiazide's side effects


• Aspirin, cholestyramine, or colestipol because they may decrease Valsartan/Hydrochlorothiazide's effectiveness


• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, celecoxib, ibuprofen) because they may decrease Valsartan/Hydrochlorothiazide's effectiveness and the risk of serious kidney problems may be increased


• Diazoxide, digoxin, or lithium because the risk of their side effects and toxic effects may be increased by Valsartan/Hydrochlorothiazide


• Insulin or other diabetes medicines (eg, glipizide, metformin) because their effectiveness may be decreased by Valsartan/Hydrochlorothiazide

This may not be a complete list of all interactions that may occur. Ask your health care provider if Valsartan/Hydrochlorothiazide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Valsartan/Hydrochlorothiazide:

Use Valsartan/Hydrochlorothiazide as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Valsartan/Hydrochlorothiazide. Talk to your pharmacist if you have questions about this information.


• Take Valsartan/Hydrochlorothiazide by mouth with or without food.


• Drinking extra fluids while you are taking Valsartan/Hydrochlorothiazide is recommended. Check with your doctor for instructions.


• Valsartan/Hydrochlorothiazide may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.


• If you take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with Valsartan/Hydrochlorothiazide.


• Continue to take Valsartan/Hydrochlorothiazide even if you feel well. Do not miss any doses.


• If you miss a dose of Valsartan/Hydrochlorothiazide, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Valsartan/Hydrochlorothiazide.

Important safety information:

• Valsartan/Hydrochlorothiazide may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Valsartan/Hydrochlorothiazide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Valsartan/Hydrochlorothiazide may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Report any light-headedness or fainting to your doctor immediately. Your risk of light-headedness or fainting may be increased if you experience diarrhea, vomiting, excessive sweating, if you do not drink enough fluids, or if you are on a low-salt (sodium) diet.


• It may take 2 to 4 weeks for Valsartan/Hydrochlorothiazide to work fully. Do not stop using Valsartan/Hydrochlorothiazide or change your dose of Valsartan/Hydrochlorothiazide without checking with your doctor.


• Valsartan/Hydrochlorothiazide contains a sulfonamide called hydrochlorothiazide, which can cause certain eye problems (myopia, angle-closure glaucoma). Your risk may be increased if you are allergic to sulfonamide medicines (eg, sulfamethoxazole) or to penicillin antibiotics (eg, amoxicillin). Untreated angle-closure glaucoma can lead to permanent vision loss. If these eye problems occur, symptoms usually occur within hours to weeks of starting Valsartan/Hydrochlorothiazide. Contact your doctor right away if you experience symptoms such as vision changes (eg, decreased vision clearness) or eye pain.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Valsartan/Hydrochlorothiazide may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Valsartan/Hydrochlorothiazide. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Tell your doctor or dentist that you take Valsartan/Hydrochlorothiazide before you receive any medical or dental care, emergency care, or surgery.


• If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.


• Your doctor may have also prescribed a potassium supplement for you. If so, follow the dosing carefully. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor.


• Check with your doctor before you use a salt substitute or a product that has potassium in it.


• Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Valsartan/Hydrochlorothiazide may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.


• Valsartan/Hydrochlorothiazide may interfere with certain lab tests, including parathyroid function. Be sure your doctor and lab personnel know you are taking Valsartan/Hydrochlorothiazide.


• Lab tests, including kidney function, blood pressure, and blood electrolytes, may be performed while you use Valsartan/Hydrochlorothiazide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Valsartan/Hydrochlorothiazide with caution in the ELDERLY; they may be more sensitive to its effects.


• Valsartan/Hydrochlorothiazide should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Valsartan/Hydrochlorothiazide may cause birth defects or fetal death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. Valsartan/Hydrochlorothiazide is found in breast milk. Do not breast-feed while taking Valsartan/Hydrochlorothiazide.

Possible side effects of Valsartan/Hydrochlorothiazide:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning, numbness, or tingling; chest pain; confusion; decrease in sexual ability; decreased urination; drowsiness; eye pain; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hoarseness; joint pain (especially in the big toe); mental or mood changes (eg, depression); muscle pain, tenderness, or cramps; nausea and vomiting; red, swollen, blistered, or peeling skin; restlessness; seizures; severe or persistent dizziness or light-headedness; severe or persistent dry mouth; shortness of breath; sluggishness; swelling of the arms or legs; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent stomach pain, yellowing of the eyes of skin); symptoms of pancreatitis (eg, severe or persistent stomach or back pain, with or without nausea or vomiting); unusual bruising or bleeding; unusual thirst, tiredness, or weakness; unusual weight gain; vision changes (eg, decreased vision clearness).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; fast or slow heartbeat; severe or unusual dizziness, drowsiness, or light-headedness; symptoms of blood electrolyte problems (eg, confusion; irregular heartbeat; mental or mood changes; muscle pain, weakness, or cramping; seizures; sluggishness); symptoms of dehydration (eg, decreased urination; dry mouth or eyes; fast heartbeat; unusual thirst, tiredness, or weakness).

Proper storage of Valsartan/Hydrochlorothiazide:

Store Valsartan/Hydrochlorothiazide at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Valsartan/Hydrochlorothiazide out of the reach of children and away from pets.

General information:

• If you have any questions about Valsartan/Hydrochlorothiazide, please talk with your doctor, pharmacist, or other health care provider.


• Valsartan/Hydrochlorothiazide is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Valsartan/Hydrochlorothiazide. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Valsartan/Hydrochlorothiazide resources

• Valsartan/Hydrochlorothiazide Use in Pregnancy & Breastfeeding
• Valsartan/Hydrochlorothiazide Drug Interactions
• Valsartan/Hydrochlorothiazide Support Group
• 15 Reviews for Valsartan/Hydrochlorothiazide - Add your own review/rating

Compare Valsartan/Hydrochlorothiazide with other medications

• High Blood Pressure

Alinia

Generic Name: Nitazoxanide
Class: Antiprotozoals, Miscellaneous
VA Class: AP109
Chemical Name: 2-acetyloxy-N-(5-nitro-2-thiazolyl)benzamide
Molecular Formula: C₁₂H₉N₃ O₅ S
CAS Number: 55981-09-4

Introduction

Antiprotozoal; nitrothiazolyl-salicylamide derivative.^{1 2}

Uses for Alinia

Cryptosporidiosis

Treatment of diarrhea caused by Cryptosporidium parvum in immunocompetent adults, adolescents, and children ≥1 year of age;^{1 12} designated an orphan drug by FDA for this use.¹³ A drug of choice for treatment of cryptosporidiosis in adults and pediatric patients who do not have HIV infection.¹²

Anti-infectives may suppress the infection, but none has been found to reliably eradicate Cryptosporidium.^{4 6 15 16}

Safety and efficacy not established for treatment of diarrhea caused by C. parvum in immunocompromised individuals (including HIV patients);¹ has not been more effective than placebo in such patients.^{1 2 12 15} CDC, NIH, IDSA, and others state that the most appropriate treatment for cryptosporidiosis in HIV-infected individuals is the use of potent antiretroviral agents (to restore immune function) and symptomatic treatment of diarrhea.^{6 15 16}

Giardiasis

Treatment of diarrhea caused by Giardia lamblia (also known as G. duodenalis or G. intestinalis) in immunocompetent adults, adolescents, and children ≥1 year of age.¹ Designated an orphan drug by FDA for treatment of intestinal giardiasis.¹³

Metronidazole, tinidazole, and nitazoxanide are drugs of choice for treatment of giardiasis.¹²

Safety and efficacy not established for treatment of giardiasis in immunocompromised individuals (including HIV patients).¹

Cestode (Tapeworm)Infections

Has been used for treatment of infections caused by Hymenolepis nana† (dwarf tapeworm).¹⁴ Praziquantel is drug of choice;¹² nitazoxanide is an alternative.¹²

Nematode (Roundworm) Infections

Has been used for treatment of ascariasis† caused by Ascaris lumbricoides.¹⁴ Albendazole, ivermectin, and mebendazole are drugs of choice for ascariasis.¹²

Has been used for treatment of trichuriasis† caused by Trichuris trichiura (whipworm).¹⁴ Mebendazole is drug of choice;¹² alternatives are albendazole and ivermectin.¹²

Alinia Dosage and Administration

Administration

Oral Administration

Administer orally twice daily with food.¹

Reconstitution

Reconstitute powder for oral suspension at the time of dispensing by adding the amount of water specified on the container in 2 portions; shake well after each addition.¹

Reconstituted suspension contains 100 mg/5 mL.¹

Shake suspension well prior to administration of each dose.¹

Oral suspension is the appropriate dosage form for children ≤11 years of age.¹ The amount of nitazoxanide in the tablet (500 mg) exceeds the recommended dosage in this age group.¹

Dosage

Nitazoxanide tablets and oral suspension are not bioequivalent.¹

Pediatric Patients

Cryptosporidiosis

Oral

Children 1–3 years of age: 100 mg every 12 hours for 3 days.^{1 12}

Children 4–11 years of age: 200 mg every 12 hours for 3 days.^{1 12}

Children ≥12 years of age: 500 mg every 12 hours for 3 days.^{1 12}

Giardiasis

Oral

Children 1–3 years of age: 100 mg every 12 hours for 3 days.^{1 12}

Children 4–11 years of age: 200 mg every 12 hours for 3 days.^{1 12}

Children ≥12 years of age: 500 mg every 12 hours for 3 days.^{1 12}

Cestode (Tapeworm) Infections†

Hymenolepsis nana Infections†

Oral

Children 1–3 years of age: 100 mg twice daily for 3 days.^{12 14}

Children 4–11 years of age: 200 mg twice daily for 3 days.^{12 14}

Children ≥12 years of age: 500 mg daily for 3 days.¹²

Adults

Cryptosporidiosis

Oral

500 mg every 12 hours for 3 days.^{1 12}

Giardiasis

Oral

500 mg every 12 hours for 3 days.¹

Cestode (Tapeworm) Infections†

Hymenolepsis nana Infections†

Oral

500 mg daily for 3 days.¹²

Cautions for Alinia

Contraindications

• 
  

  Hypersensitivity to nitazoxanide or any ingredient in the formulation.¹

  
  

Warnings/Precautions

General Precautions

Diabetes Mellitus

Individuals with diabetes mellitus and/or their caregivers should be informed that reconstituted nitazoxanide oral suspension contains 1.48 g of sucrose/5 mL.¹

Immunodeficiency

Has not been more effective than placebo for treatment of diarrhea caused by C. parvum in HIV-infected or immunocompromised patients.^{1 2 12 15}

Safety and efficacy for treatment of diarrhea caused by Giardia notestablished in immunocompromised individuals, including those with HIV infection.¹

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether distributed into milk.¹ Caution advised if used in nursing women.¹

Pediatric Use

Safety and efficacy not established in children <1 year of age.¹

Geriatric Use

Experience in those ≥65 years of age insufficient to determine whether they respond differently than younger adults.¹

The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease or drug therapy should be considered.¹ Caution advised in geriatric patients with renal and/or hepatic impairment.¹

Hepatic Impairment

Use with caution;¹ pharmacokinetics not evaluated.¹

Renal Impairment

Use with caution;¹ pharmacokinetics not evaluated.¹

Common Adverse Effects

Abdominal pain, diarrhea, nausea, vomiting, headache.¹

Interactions for Alinia

Protein-bound Drugs

Pharmacokinetic interaction possible with other highly protein-bound drugs; use with caution in patients receiving highly protein-bound drugs with a narrow therapeutic index (e.g., warfarin).¹

Drugs Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interaction unlikely; does not inhibit CYP isoenzymes.¹

Alinia Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed from GI tract and hydrolyzed to tizoxanide.¹ Both nitazoxanide and tizoxanide have antiprotozoal activity.^{1 10}

Peak plasma concentrations of tizoxanide and tizoxanide glucuronide attained within 1–4 hours; nitazoxanide undetectable in plasma.¹

The tablets and oral suspension are not bioequivalent.¹ Bioavailability of the oral suspension is 70% relative to that of the tablet.¹

Food

Food increases extent of absorption.¹

Distribution

Plasma Protein Binding

>99%.¹

Elimination

Metabolism

Rapidly hydrolyzed to tizoxanide;¹ tizoxanide subsequently undergoes conjugation, principally by glucuronidation.¹

Elimination Route

Tizoxanide eliminated in urine, bile, and feces;¹ tizoxanide glucuronide eliminated in urine and bile.¹

Special Populations

Pharmacokinetics not studied in patients with hepatic or renal impairment.¹

Stability

Storage

Oral

For Suspension

25°C (may be exposed to 15–30°C).¹

After reconstitution, store in tight container at 25°C (may be exposed to 15–30°C); discard after 7 days.¹

Tablets

25°C (may be exposed to 15–30°C).¹

ActionsActions

• 
  

  Both nitazoxanide and its metabolite, tizoxanide, have antiprotozoal activity.¹⁰

  
  


• 
  

  Antiprotozoal activity may be related principally to interference with the pyruvate:ferredoxin 2-oxidoreductase enzyme-dependent electron transfer reaction essential to anaerobic energy metabolism in susceptible organisms.¹

  
  


• 
  

  Active against sporozoites and oocysts of Cryptosporidium parvum and trophozoites of Giardia lamblia (also known as G. duodenalis or G. intestinalis).¹

  
  


• 
  

  Also active against some other organisms, including Entamoeba histolytica,¹⁰ Trichomonas vaginalis,¹⁰ and certain anaerobic and microaerophilic gram-positive and gram-negative bacteria (e.g., Helicobacter pylori).¹⁰

  
  

Advice to Patients

• 
  

  Importance of taking with food.¹

  
  


• 
  

  Advise diabetic patients and/or their caregivers that the oral suspension contains sucrose.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information. (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Nitazoxanide

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	For suspension	100 mg/5 mL	Alinia	Romark
	Tablets	500 mg	Alinia	Romark

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Alinia 500MG Tablets (ROMARK PHARMACEUTICALS): 60/$1360 or 180/$3810.02

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Romark Pharmaceuticals. Alinia (nitazoxanide) tablets and for oral suspension prescribing information. Tampa, FL: 2005 Jun.

2. Amadi B, Mwiya M, Musuku J et al. Effect of nitazoxanide on morbidity and mortality in Zambian children with cryptosporidiosis: a randomised controlled study. Lancet. 2002; 360:1375-80. [IDIS 488791] [PubMed 12423984]

3. Rossignol J-F A, Ayoub A, Ayers MS. Treatment of diarrhea caused by Cryptosporidium parvum: a prospective randomized, double-blind, placebo-controlled study of nitazoxanide. J Infect Dis. 2001; 184:103-6. [IDIS 466301] [PubMed 11398117]

4. Committee on Infectious Diseases, American Academy of Pediatrics. Redbook: 2003 report of the Committee on Infectious Diseases. 26th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2003:255-7, 283-5.

5. Scott K G-E, Meddings JB, Kirk DR et al. Intestinal infection with Giardia spp. reduces epithelial barrier function in a myosin light chain kinase-dependent fashion. Gastroenterol. 2002; 123:1179-90.

6. Chen XM, Keithly JS, Paya CV et al. Cryptosporidiosis. N Engl J Med. 2002; 346:1723-31. [PubMed 12037153]

7. Kosek M, Alcantara C, Lima AAM et al. Cryptosporidiosis: an update. Lancet Infect Dis. 2001; 1:262-9. [PubMed 11871513]

8. Guerrant RL, Gilder TV, Steiner TS et al. Practice guidelines for the management of infectious diarrhea. Clin Infect Dis. 2001; 32:331-50. [IDIS 466024] [PubMed 11170940]

9. Centers for Disease Control and Prevention. Diagnosis and management of foodborne illness. A primer for physicians. MMWR Morb Mortal Wkly Rep. 2001; 50(No. RR-2):1-69. [PubMed 11215787]

10. Adagu IS, Nolder D, Warhurst DC et al. In vitro activity of nitazoxanide and related compounds against isolates of Giardia intestinalis, Entamoeba histolytica, and Trichomonas vaginalis. J Antimicrob Chemother. 2002; 49:103-14. [PubMed 11751773]

11. Romark Laboratories, Tampa, FL: personal communication.

12. Anon. Drugs for parasitic infections. Med Lett Drugs Ther. Aug 2004. From the Medical Letter web site ().

13. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414). Rockville, MD; 2002 Oct 15. From FDA web site (). Accessed 2003 Feb 24.

14. Juan JO, Lopez Chegne N, Gargala G et al. Comparative clinical studies of nitazoxanide, albendazole and praziquantel in the treatment of ascariasis, trichuriasis and hymenolepiasis in children from Peru. Trans R Soc Trop Med Hyg. 2002; 96:193-6. [PubMed 12055813]

15. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-infected adults and adolescents: recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association/Infectious Diseases Society of America. MMWR Morb Mortal Wkly Rep. 2004; 53(No. RR-15):1-112.

16. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-exposed and infected children: recommendations from CDC, the National Institutes of Health, and the Infectious Diseases Society of America. MMWR Morb Mortal Wkly Rep. 2004; 53(No. RR-14):1-92.

More Alinia resources

• Alinia Side Effects (in more detail)
• Alinia Dosage
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• Alinia Drug Interactions
• Alinia Support Group
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• Alinia Prescribing Information (FDA)


• Alinia MedFacts Consumer Leaflet (Wolters Kluwer)


• Alinia Concise Consumer Information (Cerner Multum)


• Alinia Advanced Consumer (Micromedex) - Includes Dosage Information


• Nitazoxanide Professional Patient Advice (Wolters Kluwer)

Compare Alinia with other medications

• Amebiasis
• Ascariasis
• Cryptosporidiosis
• Giardiasis
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