Hydromet

Hydrocodone can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Avoid driving or operating machinery until you know how this medicine will affect you.

You should not breast-feed while taking this medicine.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Call your doctor right away if you have weak or shallow breathing, confusion, severe weakness, or extreme drowsiness.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A hydrocodone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pale skin, blue-colored lips, and fainting.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with hydrocodone.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how homatropine and hydrocodone will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

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

Like other narcotic medicines, hydrocodone can slow your breathing. Death may occur if breathing becomes too weak.

Stop using homatropine and hydrocodone and call your doctor at once if you have:

• severe weakness, severe drowsiness, confusion;

• weak or shallow breathing;

• severe constipation, stomach pain;

• painful or difficult urination; or

• a light-headed feeling, like you might pass out.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common side effects may include:

• drowsiness, confusion;

• constipation, nausea, vomiting;

• urination problems; or

• trouble breathing.

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.

• It is used to relieve coughing.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Chest pain or pressure or a fast heartbeat.
• Feeling confused.
• A heartbeat that does not feel normal.
• Hallucinations (seeing or hearing things that are not there).
• Seizures.
• Very bad belly pain.
• Very bad headache.
• Shakiness.
• Change in eyesight.
• Very upset stomach or throwing up.
• Feeling very sleepy.
• Very hard stools (constipation).
• Feeling very tired or weak.
• Trouble passing urine.
• Anxiety.
• Mood changes.
• This medicine may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution contains hydrocodone (dihydrocodeinone) bitartrate, USP, a semisynthetic centrally-acting opioid antitussive. Homatropine methylbromide, USP is included in a subtherapeutic amount to discourage deliberate overdosage.

Each teaspoonful (5 mL) contains:

Hydrocodone Bitartrate, USP ........................ 5 mg

Homatropine Methylbromide, USP ............... 1.5 mg

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution also contains: artificial cherry flavor, anhydrous citric acid, D&C Red #33, FD&C Blue #1, FD&C Red #40, methylparaben, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate, and sucrose.

The hydrocodone component is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5), a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine, has a molecular weight of 494.49, and may be represented by the following structural formula:

Homatropine methylbromide, USP is a 3α-hydroxy-8-methyl-1αH, 5αH-tropanium bromide mandelate; a white crystal or fine white crystalline powder, with a molecular weight of 370.28.

General

Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is provided.

Special Risk Patients

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution should be given with caution to certain patients such as the elderly or debilitated, and those with severe impairment of hepatic or renal functions, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture, asthma, and narrow-angle glaucoma.

Information for Patients

Inform patients and caregivers that potentially fatal additive effects may occur if Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution is used with benzodiazepines or other CNS depressants, including alcohol. Because of this risk, patients should avoid concomitant use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution with benzodiazepines or other CNS depressants, including alcohol (see WARNINGS, PRECAUTIONS - Drug Interactions).

Hydrocodone may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution should be cautioned accordingly.

Patients should be advised to measure Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose. Keep out of the reach of children.

Drug Interactions

The use of benzodiazepines, opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants (including alcohol) concomitantly with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution may cause an additive CNS depressant effect, profound sedation, respiratory depression, coma, and death and should be avoided (see WARNINGS).

The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution in animals to evaluate the carcinogenic and mutagenic potential and the effect on fertility have not been conducted.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution. It is also not known whether Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution should be given to a pregnant woman only if clearly needed.

Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose.

Labor and Delivery

As with all opioids, administration of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of hydrocodone bitartrate and homatropine methylbromide in pediatric patients under six have not been established. The use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution in children less than 6 years of age has been associated with cases of fatal respiratory depression (see ADVERSE REACTIONS – Respiratory Depression). Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution should be used with caution in pediatric patients 6 years of age and older (see WARNINGS – Pediatric Use).

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution is a red colored, cherry flavored oral solution containing 5 mg hydrocodone bitartrate, USP and 1.5 mg homatropine methylbromide, USP per 5 mL, and is available in one pint (473 mL) bottles (NDC 0472-1030-16).

Store at controlled room temperature 15° to 30°C (59° to 86°F).

Dispense in a tight, light-resistant container as defined in the USP.

Oral prescription where permitted by State Law.

Manufactured by:
G&W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080 USA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

I602-1090 GW7167
Rev. 01/07