Nydrazid

Isoniazid is a prescription medication used in the prevention and treatment of tuberculosis. Isoniazid belongs to a group of drugs called antitubercular agents. It is believed to work by preventing the bacteria from multiplying in the body.

Isoniazid is used to prevent or treat tuberculosis, alone or in combination with other medicines.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tell your doctor if you are allergic to isoniazid or any other medicines.

Isoniazid has caused severe and sometimes fatal hepatitis (see "FDA Warning"). Daily ingestion of alcohol may be associated with a higher incidence of isoniazid hepatitis. You should avoid alcohol while taking this medicine.

Tell your doctor if you have any other medical problems such as liver disease, kidney disease, or seizure disorder. With the presence of these conditions, there may be an increase risk of side effects or seizures.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if isoniazid will harm your unborn baby.

In the U.S.

• Nydrazid

In Canada

• Pms-Isoniazid

Available Dosage Forms:

• Syrup
• Tablet
• Solution

Therapeutic Class: Antitubercular

Chemical Class: Isonicotinic Acid

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Isoniazid can cause serious side effects in any patient. Therefore, it is especially important that you discuss with the child's doctor the good that this medicine may do as well as the risks of using it.

Geriatric

Hepatitis may be especially likely to occur in patients over 50 years of age, who are usually more sensitive than younger adults to the effects of isoniazid.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetaminophen
• Amiodarone
• Bupropion
• Carbamazepine
• Domperidone
• Donepezil
• Eliglustat
• Glimepiride
• Ketoconazole
• Levodopa
• Piperaquine
• Rifampin
• Tegafur

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aminosalicylic Acid
• Diazepam
• Disulfiram
• Enflurane
• Fosphenytoin
• Meperidine
• Phenytoin
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• food
• Tyramine Containing Food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of) or
• Liver disease—There may be an increased chance of hepatitis with daily drinking of alcohol or in patients with liver disease

• Kidney disease (severe)—There may be an increased chance of side effects in patients with severe kidney disease

• Seizure disorders such as epilepsy—There may be an increased chance of seizures (convulsions) in some patients

This section provides information on the proper use of a number of products that contain isoniazid. It may not be specific to Nydrazid. Please read with care.

Make certain your health care professional knows if you are on a low-sodium, low-sugar, or any other special diet. Most medicines contain more than just the active ingredient, and many liquid medicines contain alcohol.

If you are taking isoniazid by mouth and it upsets your stomach, take it with food. Antacids may also help. However, do not take aluminum-containing antacids within 1 hour of taking isoniazid. They may keep this medicine from working properly.

For patients taking the oral liquid form of isoniazid:

• Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

To help clear up your tuberculosis (TB) completely, it is very important that you keep taking this medicine for the full time of treatment, even if you begin to feel better after a few weeks. You may have to take it every day for as long as 6 months to 2 years. It is important that you do not miss any doses.

Your doctor may also want you to take pyridoxine (e.g., Hexa-Betalin, vitamin B 6) every day to help prevent or lessen some of the side effects of isoniazid. This is not usually needed in children, who receive enough pyridoxine in their diet. If it is needed, it is very important to take pyridoxine every day along with this medicine. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (tablets, syrup):
  • For preventing the return (reactivation) of tuberculosis:
    • Adults and teenagers—300 milligrams (mg) once a day.
    • Children—Dose is based on body weight. The usual dose is 10 mg per kilogram (kg) (4.5 mg per pound) of body weight, up to 300 mg, once a day.
  • For treatment of tuberculosis:
    • Adults and teenagers—300 mg once a day; or 15 mg per kg (6.8 mg per pound) of body weight, up to 900 mg, two times a week or three times a week, depending on the schedule your doctor chooses for you.
    • Children—Dose is based on body weight. The usual dose is 10 to 20 mg per kg (4.5 to 9.1 mg per pound) of body weight, up to 300 mg, once a day; or 20 to 40 mg per kg (9.1 to 18.2 mg per pound) of body weight, up to 900 mg, two times a week or three times a week, depending on the schedule your doctor chooses for you.
• For injection dosage form:
  • For preventing the return (reactivation) of tuberculosis:
    • Adults and teenagers—300 mg once a day.
    • Children—Dose is based on body weight. The usual dose is 10 mg per kg (4.5 mg per pound) of body weight, up to 300 mg, once a day.
  • For treatment of tuberculosis:
    • Adults and teenagers—300 mg once a day; or 15 mg per kg (6.8 mg per pound) of body weight, up to 900 mg, two times a week or three times a week, depending on the schedule your doctor chooses for you.
    • Children—Dose is based on body weight. The usual dose is 10 to 20 mg per kg (4.5 to 9.1 mg per pound) of body weight, up to 300 mg, once a day; or 20 to 40 mg per kg (9.1 to 18.2 mg per pound) of body weight, up to 900 mg, two times a week or three times a week, depending on the schedule your doctor chooses for you.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Nydrazid, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Nydrazid (isoniazid injection). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Nydrazid.

Review Date: October 4, 2017