Hydromet | Medidex

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Overview

What is Hydromet?

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 ............... 15 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 49449, 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 37028.

What does Hydromet look like?

What are the available doses of Hydromet?

Sorry No records found.

What should I talk to my health care provider before I take Hydromet?

Sorry No records found

How should I use Hydromet?

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution is indicated for the symptomatic relief of cough in adults and children 6 years of age and older.

It is important that Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution is measured with an accurate measuring device (see ). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose.

Adults and Adolescents 12 Years of Age and Older

5 mL (1 teaspoonful) of the oral solution every 4 to 6 hours as needed; do not exceed 30 mL (6 teaspoonfuls) in 24 hours.

Children 6 to 11 Years of Age

2.5 mL (1/2 teaspoonful) of the oral solution every 4 to 6 hours as needed; do not exceed 15 mL (3 teaspoonfuls) in 24 hours.

What interacts with Hydromet?

Sorry No Records found

What are the warnings of Hydromet?

Sorry No Records found

What are the precautions of Hydromet?

Sorry No Records found

What are the side effects of Hydromet?

Sorry No records found

What should I look out for while using Hydromet?

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution should not be administered to patients who are hypersensitive to hydrocodone or homatropine methylbromide.

What might happen if I take too much Hydromet?

Signs and Symptoms

Serious overdosage with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur. The ingestion of very large amounts of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution may, in addition, result in acute homatropine intoxication.

Treatment

Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The opioid antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to opioids including hydrocodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. For further information, see full prescribing information for naloxone hydrochloride. An antagonist should not be administered in the absence of clinically significant respiratory depression. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug.

How should I store and handle Hydromet?

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution is a red colored, cherry flavored oral solution containing 5 mg hydrocodone bitartrate, USP and 15 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: Distributed by: I602-1090 GW7167Rev. 01/07Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution is a red colored, cherry flavored oral solution containing 5 mg hydrocodone bitartrate, USP and 15 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: Distributed by: I602-1090 GW7167Rev. 01/07Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution is a red colored, cherry flavored oral solution containing 5 mg hydrocodone bitartrate, USP and 15 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: Distributed by: I602-1090 GW7167Rev. 01/07Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution is a red colored, cherry flavored oral solution containing 5 mg hydrocodone bitartrate, USP and 15 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: Distributed by: I602-1090 GW7167Rev. 01/07Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution is a red colored, cherry flavored oral solution containing 5 mg hydrocodone bitartrate, USP and 15 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: Distributed by: I602-1090 GW7167Rev. 01/07Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution is a red colored, cherry flavored oral solution containing 5 mg hydrocodone bitartrate, USP and 15 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: Distributed by: I602-1090 GW7167Rev. 01/07Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution is a red colored, cherry flavored oral solution containing 5 mg hydrocodone bitartrate, USP and 15 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: Distributed by: I602-1090 GW7167Rev. 01/07

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Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Hydrocodone is a semisynthetic opioid antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. In excessive doses, hydrocodone, like other opium derivatives, will depress respiration. The effects of hydrocodone in therapeutic doses on the cardiovascular system are insignificant. Hydrocodone can produce miosis, euphoria, physical and physiological dependence.

Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 236 ± 52 ng/mL. Maximum serum levels were achieved at 13 ± 03 hours and the half-life was determined to be 38 ± 03 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α- and 6-ß-hydroxymetabolites.

Non-Clinical Toxicology

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution should not be administered to patients who are hypersensitive to hydrocodone or homatropine methylbromide.

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 )

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

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.

Central Nervous System

Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes.

Gastrointestinal System

Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution may produce constipation.

Genitourinary System

Ureteral spasm, spasm of vesicle sphincters and urinary retention have been reported with opiates.

Respiratory Depression

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see ). Use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution in children less than 6 years of age has been associated with fatal respiratory depression. Overdose with hydrocodone bitartrate and homatropine methylbromide in children 6 years of age and older, in adolescents, and in adults has been associated with fatal respiratory depression. Postmarketing events seen in children under 6 years of age include accidental overdose, bronchopneumonia, coma, cyanosis, death, death neonatal, dyspnea, pulmonary edema, respiratory arrest, and respiratory depression. Postmarketing events seen in patients older than 6 years of age include accidental overdose, cardio-respiratory arrest, death due to drug toxicity, non-accidental overdose, and overdose.

Dermatological

Skin rash, pruritus.

To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Disclaimer:

hydrocodone bitartrate and homatropine methylbromide

Overview

What is Hydromet?

What does Hydromet look like?

What are the available doses of Hydromet?

What should I talk to my health care provider before I take Hydromet?

How should I use Hydromet?

What interacts with Hydromet?

What are the warnings of Hydromet?

What are the precautions of Hydromet?

What are the side effects of Hydromet?

What should I look out for while using Hydromet?

What might happen if I take too much Hydromet?

How should I store and handle Hydromet?

Clinical Information

Chemical Structure

Clinical Pharmacology

Non-Clinical Toxicology

Reference

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Disclaimer:

hydrocodone bitartrate and homatropine methylbromide

Overview

What is Hydromet?

What does Hydromet look like?

What are the available doses of Hydromet?

What should I talk to my health care provider before I take Hydromet?

How should I use Hydromet?

What interacts with Hydromet?

What are the warnings of Hydromet?

What are the precautions of Hydromet?

What are the side effects of Hydromet?

What should I look out for while using Hydromet?

What might happen if I take too much Hydromet?

How should I store and handle Hydromet?

Clinical Information

Chemical Structure

Clinical Pharmacology

Non-Clinical Toxicology

Reference

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

Review

Rate this treatment and share your opinion

Helpful tips to write a good review:

Reason for Taking This Treatment

Click the stars to rate this treatment

Effectiveness (required)

Ease of Use (required)

Satisfaction (required)

Write a brief description of your experience with this treatment:

Optional Information

User Reviews & Ratings - losartan oral

«losartan oral Information

Overall User Ratings

User Reviews Learn about User Reviews

Related to losartan oral

Professional

Tips

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