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Reprexain

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Overview

What is Reprexain?



What does Reprexain look like?



What are the available doses of Reprexain?

Sorry No records found.

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

Sorry No records found

How should I use Reprexain?

WARNINGS

Carefully consider the potential benefits and risks of REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) and other treatment options before deciding to use REPREXAIN™. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ). After observing the response to initial therapy with REPREXAIN™, the dose and frequency should be adjusted to suit an individual patient’s needs. For the short-term (generally less than 10 days) management of acute pain, the recommended dose of REPREXAIN™ is one tablet every 4 to 6 hours, as necessary. Dosage should not exceed 5 tablets in a 24-hour period. It should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related. The lowest effective dose or the longest dosing interval should be sought for each patient (see), especially in the elderly. After observing the initial response to therapy with REPREXAIN™, the dose and frequency of dosing should be adjusted to suit the individual patient’s need, without exceeding the total daily dose recommended.


What interacts with Reprexain?

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What are the warnings of Reprexain?

Sorry No Records found


What are the precautions of Reprexain?

Sorry No Records found


What are the side effects of Reprexain?

Sorry No records found


What should I look out for while using Reprexain?

REPREXAIN™ is contraindicated in patients with known hypersensitivity to hydrocodone or ibuprofen. Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. REPREXAIN™ should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see and ). REPREXAIN™ is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see ).

CARDIOVASCULAR EFFECTS

GI WARNINGS

CONTRAINDICATIONS

Hypertension

Congestive Heart Failure and Edema

Misuse Abuse and Diversion of Opioids

DRUG ABUSE AND DEPENDENCE

Respiratory Depression

Head Injury and Increased Intracranial Pressure

Acute Abdominal Conditions

Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding and Perforation

Renal Effects

Advanced Renal Disease

Anaphylactoid Reactions

CONTRAINDICATIONS

PRECAUTIONS

Pre-existing Asthma

Skin Reactions

Pregnancy

As with other NSAID-containing products, REPREXAIN™ should be avoided in late pregnancy because it may cause premature closure of the ductus arteriosus.


What might happen if I take too much Reprexain?

Following an acute overdosage, toxicity may result from hydrocodone and/or ibuprofen. Signs and Symptoms Serious overdose 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. Ibuprofen Component Symptoms include gastrointestinal irritation with erosion and hemorrhage or perforation, kidney damage, liver damage, heart damage, hemolytic anemia, agranulocytosis, thrombocytopenia, aplastic anemia, and meningitis. Other symptoms may include headache, dizziness, tinnitus, confusion, blurred vision, mental disturbances, skin rash, stomatitis, edema, reduced retinal sensitivity, corneal deposits, and hyperkalemia. Primary attention should be given to the re-establishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. Naloxone, a narcotic antagonist, can reverse respiratory depression and coma associated with opioid overdose or unusual sensitivity to opioids, including hydrocodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered intravenously with simultaneous efforts at respiratory resuscitation. Since the duration of action of hydrocodone may exceed that of the naloxone, the patient should be kept under continuous surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. Supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug. In cases where consciousness is impaired it may be inadvisable to perform gastric lavage. If gastric lavage is performed, little drug will likely be recovered if more than an hour has elapsed since ingestion. Ibuprofen is acidic and is excreted in the urine; therefore, it may be beneficial to administer alkali and induce diuresis. In addition to supportive measures the use of oral activated charcoal may help to reduce the absorption and reabsorption of ibuprofen. Dialysis is not likely to be effective for removal of ibuprofen because it is very highly bound to plasma proteins.


How should I store and handle Reprexain?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse.   Bottles of 100: NDC 63717-900-01Sample boxes of 10 tablets: NDC 63717-900-995 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse.  Bottles of 100: NDC 63717-901-01Sample boxes of 10 tablets: NDC 63717-901-9910 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse.  Bottles of 100: NDC 63717-902-01Sample boxes of 10 tablets: NDC 63717-902-99 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Madison, MS 39110 Rev. 12/08 HI251NDC 63717-900-01Reprexain™ CIII(hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mgRx only100 TabletsHawthorn Pharmaceuticals, Inc.Each tablet contains:Hydrocodone bitartrate USP, 2.5 mgIbuprofen USP, 200 mgUsual Dosage:DispenseStore(59-86F).Mfd. for:Madison, Ms 39110HI200 11/05


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Clinical Information

Chemical Structure

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Clinical Pharmacology

In single-dose studies of post surgical pain (abdominal, gynecological, orthopedic), 940 patients were studied at doses of one or two tablets. REPREXAIN™ produced greater efficacy than placebo and each of its individual components given at the same dose. No advantage was demonstrated for the two-tablet dose.

Non-Clinical Toxicology
REPREXAIN™ is contraindicated in patients with known hypersensitivity to hydrocodone or ibuprofen. Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. REPREXAIN™ should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see and ). REPREXAIN™ is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see ).

CARDIOVASCULAR EFFECTS

GI WARNINGS

CONTRAINDICATIONS

Hypertension

Congestive Heart Failure and Edema

Misuse Abuse and Diversion of Opioids

DRUG ABUSE AND DEPENDENCE

Respiratory Depression

Head Injury and Increased Intracranial Pressure

Acute Abdominal Conditions

Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding and Perforation

Renal Effects

Advanced Renal Disease

Anaphylactoid Reactions

CONTRAINDICATIONS

PRECAUTIONS

Pre-existing Asthma

Skin Reactions

Pregnancy

As with other NSAID-containing products, REPREXAIN™ should be avoided in late pregnancy because it may cause premature closure of the ductus arteriosus.

In patients receiving mercaptopurine or azathioprine, the concomitant administration of 300-600 mg of allopurinol per day will require a reduction in dose to approximately one-third to one-fourth of the usual dose of mercaptopurine or azathioprine. Subsequent adjustment of doses of mercaptopurine or azathioprine should be made on the basis of therapeutic response and the appearance of toxic effects (see ).

It has been reported that allopurinol prolongs the half-life of the anticoagulant, dicumarol. The clinical basis of this drug interaction has not been established but should be noted when allopurinol is given to patients already on dicumarol therapy.

Since the excretion of oxipurinol is similar to that of urate, uricosuric agents, which increase the excretion of urate, are also likely to increase the excretion of oxipurinol and thus lower the degree of inhibition of xanthine oxidase. The concomitant administration of uricosuric agents and allopurinol has been associated with a decrease in the excretion of oxypurines (hypoxanthine and xanthine) and an increase in urinary uric acid excretion compared with that observed with allopurinol alone. Although clinical evidence to date has not demonstrated renal precipitation of oxypurines in patients either on allopurinol alone or in combination with uricosuric agents, the possibility should be kept in mind.

The reports that the concomitant use of allopurinol and thiazide diuretics may contribute to the enhancement of allopurinol toxicity in some patients have been reviewed in an attempt to establish a cause-and-effect relationship and a mechanism of causation. Review of these case reports indicates that the patients were mainly receiving thiazide diuretics for hypertension and that tests to rule out decreased renal function secondary to hypertensive nephropathy were not often performed. In those patients in whom renal insufficiency was documented, however, the recommendation to lower the dose of allopurinol was not followed. Although a causal mechanism and a cause-and-effect relationship have not been established, current evidence suggests that renal function should be monitored in patients on thiazide diuretics and allopurinol even in the absence of renal failure, and dosage levels should be even more conservatively adjusted in those patients on such combined therapy if diminished renal function is detected.

An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with allopurinol compared to patients who are not receiving both drugs. The cause of the reported association has not been established. Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease, except leukemia, in the presence of allopurinol. However, in a well-controlled study of patients with lymphoma on combination therapy, allopurinol did not increase the marrow toxicity of patients treated with cyclophosphamide, doxorubicin, bleomycin, procarbazine and/or mechlorethamine.

Tolbutamide’s conversion to inactive metabolites has been shown to be catalyzed by xanthine oxidase from rat liver. The clinical significance, if any, of this observation is unknown.

Chlorpropamide’s plasma half-life may be prolonged by allopurinol, since allopurinol and chlorpropamide may compete for excretion in the renal tubule. The risk of hypoglycemia secondary to this mechanism may be increased if allopurinol and chlorpropamide are given concomitantly in the presence of renal insufficiency.

Rare reports indicate that cyclosporine levels may be increased during concomitant treatment with allopurinol. Monitoring of cyclosporine levels and possible adjustment of cyclosporine dosage should be considered when these drugs are co-administered.

General

Special Risk Patients

Cough Reflex

Hepatic Effects

Hematological Effects

Pre-existing Asthma

Aseptic Meningitis

REPREXAIN™ was administered to approximately 300 pain patients in a safety study that employed dosages and a duration of treatment sufficient to encompass the recommended usage (see ). Adverse event rates generally increased with increasing daily dose. The event rates reported below are from approximately 150 patients who were in a group that received one tablet of REPREXAIN™ an average of three to four times daily. The overall incidence rates of adverse experiences in the trials were fairly similar for this patient group and those who received the comparison treatment, acetaminophen 600 mg with codeine 60 mg. The following lists adverse events that occurred with an incidence of 1% or greater in clinical trials of REPREXAIN™, without regard to the causal relationship of the events to the drug. To distinguish different rates of occurrence in clinical studies, the adverse events are listed as follows: : Abdominal pain*; Asthenia*; Fever; Flu syndrome; Headache (27%); Infection*; Pain. : Palpitations; Vasodilation. : Anxiety*; Confusion; Dizziness (14%); Hypertonia; Insomnia*; Nervousness*; Paresthesia; Somnolence (22%); Thinking abnormalities. : Anorexia; Constipation (22%); Diarrhea*; Dry mouth*; Dyspepsia (12%); Flatulence*; Gastritis; Melena; Mouth ulcers; Nausea (21%); Thirst; Vomiting*. : Edema*. : Dyspnea; Hiccups; Pharyngitis; Rhinitis. : Pruritus*; Sweating*. : Tinnitus. : Urinary frequency. Incidence less than 1% Body as a Whole: Allergic reaction. Cardiovascular: Arrhythmia; Hypotension; Tachycardia. Central Nervous System: Agitation; Abnormal dreams; Decreased libido; Depression; Euphoria; Mood changes; Neuralgia; Slurred speech; Tremor, Vertigo. Digestive: Chalky stool; “Clenching teeth”; Dysphagia; Esophageal spasm; Esophagitis; Gastroenteritis; Glossitis; Liver enzyme elevation. Metabolic and Nutritional: Weight decrease. Musculoskeletal: Arthralgia; Myalgia. Respiratory: Asthma; Bronchitis; Hoarseness; Increased cough; Pulmonary congestion; Pneumonia; Shallow breathing; Sinusitis. Skin and Appendages: Rash; Urticaria. Special Senses: Altered vision; Bad taste; Dry eyes. Urogenital

Misuse Abuse and Diversion of Opioids

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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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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

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).