PENTAZOCINE HCL AND NALOXONE HCL

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Overview

What is PENTAZOCINE HCL AND NALOXONE HCL?

Pentazocine and naloxone hydrochlorides tablets USP contain pentazocine hydrochloride USP, equivalent to 50 mg base, a member of the benzazocine series (also known as the benzomorphan series), and naloxone hydrochloride USP, equivalent to 0.5 mg base.

Pentazocine and naloxone hydrochlorides tablets are an analgesic for oral administration.

Chemically, pentazocine hydrochloride is (2*, 6*, 11*)-1,2,3,4,5,6-Hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol hydrochloride, a white, crystalline substance soluble in acidic aqueous solutions. It has the following structural formula:

Chemically, naloxone hydrochloride is 17-AIlyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride. It is a slightly off-white powder, and is soluble in water and dilute acids. It has the following structural formula:

Each tablet, for oral administration, contains pentazocine hydrochloride USP, equivalent to 50 mg of pentazocine, and naloxone hydrochloride USP, equivalent to 0.5 mg of naloxone. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, D and C Yellow No. 10 Al-lake, FD and C Blue No. 1 Al-lake, FD and C Yellow No. 6 Al-lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium lauryl sulfate.

What does PENTAZOCINE HCL AND NALOXONE HCL look like?

What are the available doses of PENTAZOCINE HCL AND NALOXONE HCL?

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What should I talk to my health care provider before I take PENTAZOCINE HCL AND NALOXONE HCL?

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How should I use PENTAZOCINE HCL AND NALOXONE HCL?

Pentazocine and naloxone hydrochlorides tablets are indicated for the relief of moderate to severe pain.

Pentazocine and naloxone hydrochlorides tablets are indicated for oral use only.

Adults.

When anti-inflammatory or antipyretic effects are desired in addition to analgesia, aspirin can be administered concomitantly with this product.

Pediatric Patients.

Duration of Therapy.

What interacts with PENTAZOCINE HCL AND NALOXONE HCL?

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What are the warnings of PENTAZOCINE HCL AND NALOXONE HCL?

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What are the precautions of PENTAZOCINE HCL AND NALOXONE HCL?

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What are the side effects of PENTAZOCINE HCL AND NALOXONE HCL?

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What should I look out for while using PENTAZOCINE HCL AND NALOXONE HCL?

Pentazocine and naloxone hydrochlorides tablets should not be administered to patients who are hypersensitive to either pentazocine or naloxone.

What might happen if I take too much PENTAZOCINE HCL AND NALOXONE HCL?

Manifestations.

Treatment.

How should I store and handle PENTAZOCINE HCL AND NALOXONE HCL?

Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Please refer to current USP.Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure.KEEP OUT OF REACH OF CHILDRENStore at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Please refer to current USP.Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure.KEEP OUT OF REACH OF CHILDRENStore at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Please refer to current USP.Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure.KEEP OUT OF REACH OF CHILDRENPentazocine and Naloxone Hydrochlorides Tablets USP are light green, scored, capsule shaped tablets debossed to the left of the score, over to the right of the score and on the reverse side supplied in bottles of 100.Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.30158-4Pentazocine and Naloxone Hydrochlorides Tablets USP are light green, scored, capsule shaped tablets debossed to the left of the score, over to the right of the score and on the reverse side supplied in bottles of 100.Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.30158-4Pentazocine and Naloxone Hydrochlorides Tablets USP are light green, scored, capsule shaped tablets debossed to the left of the score, over to the right of the score and on the reverse side supplied in bottles of 100.Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.30158-4Pentazocine and Naloxone Hydrochlorides Tablets USP are light green, scored, capsule shaped tablets debossed to the left of the score, over to the right of the score and on the reverse side supplied in bottles of 100.Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.30158-4Pentazocine and Naloxone Hydrochlorides Tablets USP are light green, scored, capsule shaped tablets debossed to the left of the score, over to the right of the score and on the reverse side supplied in bottles of 100.Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.30158-4

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Pentazocine is a potent analgesic which when administered orally in a 50 mg dose appears equivalent in analgesic effect to 60 mg (1 grain) of codeine. Onset of significant analgesia usually occurs between 15 and 30 minutes after oral administration, and duration of action is usually three hours or longer. Onset and duration of action and the degree of pain relief are related both to dose and the severity of pretreatment pain. Pentazocine weakly antagonizes the analgesic effects of morphine and meperidine; in addition, it produces incomplete reversal of cardiovascular, respiratory, and behavioral depression induced by morphine and meperidine. Pentazocine has about 1/50 the antagonistic activity of nalorphine. It also has sedative activity.

Pentazocine is well absorbed from the gastrointestinal tract. Concentrations in plasma coincide closely with the onset, duration, and intensity of analgesia; peak values occur 1 to 3 hours after oral administration. The half-life in plasma is 2 to 3 hours.

Pentazocine is metabolized in the liver and excreted primarily in the urine. Pentazocine passes into the fetal circulation.

Naloxone when administered orally at 0.5 mg has no pharmacologic activity. Naloxone hydrochloride administered parenterally at the same dose is an effective antagonist to pentazocine and a pure antagonist to narcotic analgesics.

Pentazocine and naloxone hydrochlorides tablets are a potent analgesic when administered orally. However the presence of naloxone in pentazocine and naloxone naloxone hydrochlorides tablets will prevent the effect of pentazocine if the product is misused by injection.

Studies in animals indicate that the presence of naloxone does not affect pentazocine analgesia when the combination is given orally. If the combination is given by injection the action of pentazocine is neutralized.

Non-Clinical Toxicology

Pentazocine and naloxone hydrochlorides tablets should not be administered to patients who are hypersensitive to either pentazocine or naloxone.

Additive adverse effects resulting from cholinergic blockade may occur when hyoscyamine sulfate is administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines.

Antacids may interfere with the absorption of hyoscyamine sulfate. Administer hyoscyamine sulfate before meals; antacids after meals.

Drug Dependence.

Head Injury and Increased Intracranial Pressure.

Usage with Alcohol.

Patients Receiving Narcotics.

Certain Respiratory Conditions.

Acute CNS Manifestations.

Caution should be used when pentazocine is administered to patients prone to seizures; seizures have occurred in a few such patients in association with the use of pentazocine though no cause and effect relationship has been established.

Decreased metabolism of pentazocine by the liver in extensive liver disease may predispose to accentuation of side effects. Although laboratory tests have not indicated that pentazocine causes or increases renal or hepatic impairment, the drug should be administered with caution to patients with such impairment.

In prescribing pentazocine for long-term use, the physician should take precautions to avoid increases in doses by the patient.

Narcotic drug products are generally considered to elevate biliary tract pressure for varying periods following their administration. Some evidence suggests that pentazocine may differ from other marketed narcotics in this respect (i.e., it causes little or no elevation in biliary tract pressures). The clinical significance of these findings, however, is not yet known.

Cardiovascular:

Respiratory:

Acute CNS Manifestations:

Other CNS Effects:

Autonomic:

Gastrointestinal:

Allergic:

Ophthalmic:

Hematologic:

Other:

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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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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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