Drug Catalog - Product Detail
BUTALBITAL-ACETAMNPHN-CAFF W/COD CAP 50-325-40-30MG 100CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00603-2553-21 | PAR PHARMACEUTICALS | 100 | 50-325-40-30MG | CAPSULE |
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Description
11 DESCRIPTION Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in capsule form for oral administration. Each capsule contains: Butalbital, USP ............................ 50 mg Acetaminophen, USP ................ 325 mg Caffeine, USP .............................. 40 mg Codeine phosphate, USP ............ 30 mg Butalbital (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula: Acetaminophen (4'hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Caffeine (1,3,7trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula: Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate) is an opioid agonist. It has the following structural formula: Chemical structure of Butalbital Chemical structure of Acetaminophen Chemical structure of Caffeine Chemical structure of Codeine Phosphate Inactive Ingredients: black iron oxide, colloidal silicon dioxide, FD&C Blue #1, gelatin, magnesium stearate, pregelatinized corn starch, and titanium dioxide.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules: Light blue opaque cap with a grey, opaque body. Cap is imprinted in black with “V”. Body is imprinted with “3109” in black. Bottles of 100: NDC 0603-2553-21 Store and Dispense At 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; in a tight, light-resistant container as defined in the USP. Keep out of reach of children
Indications & Usage
1 INDICATIONS AND USAGE Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1) ], reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsule is a combination product of butalbital, a barbiturate; acetaminophen; caffeine, a methylxanthine; and codeine phosphate, an opioid agonist; and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesic and alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate analgesics): Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. ( 2.1 ) Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. ( 2.1 ) Initiate treatment with one or two capsules every 4 hours as needed for pain. Total daily dosage should not exceed 6 capsules. ( 2.2 ) Do not stop Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules abruptly in a physically dependent patient. ( 2.3 ) 2.1 Important Dosage and Administration Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ]. Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1) ] . Evidence supporting the efficacy and safety of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules in the treatment of multiple recurrent headaches is unavailable. 2.2 Dosing Information One or two capsules every 4 hours as needed for pain. Total daily dosage should not exceed 6 capsules. 2.3 Discontinuation of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules While not indicated for around-the-clock therapy, when a patient who has been taking Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules regularly and may be physically dependent no longer requires therapy with Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules in a physically dependent patient [see Warnings and Precautions (5.17) , Drug Abuse and Dependence (9.3) ].