BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE - UNII:Q830PW7520)

Commercializzato da:

Physicians Total Care, Inc.

INN (Nome Internazionale):

BUTALBITAL

Composizione:

BUTALBITAL 50 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy of butalbital, aspirin, caffeine, and codeine phosphate capsules is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: butalbital, aspirin, caffeine, and codeine phosphate capsules; codeine; Butalbital, Aspirin, and Caffeine Capsules, USP; and placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. Butalbital, aspirin, caffeine, and codeine phosphate capsules proved statistically significantly superior to each of its components (Butalbital, Aspirin, and Caffeine Capsules, USP and codeine) and to placebo on measures of pain relief. Evidence supporting the efficacy and safety of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP in the treatmen

Dettagli prodotto:

Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP Blue cap with a yellow body. Cap is imprinted with “WATSON” in red. Body is imprinted with “3546” in red. Supplied in: bottles of 20    NDC 54868-1037-1 bottles of 30    NDC 54868-1037-3 bottles of 60    NDC 54868-1037-5 bottles of 120  NDC 54868-1037-4 which are supplied with child-resistant closures. Below 25°C (77°F); tight container. Protect from moisture. Rx only Watson Laboratories, Inc. Corona, CA 92880 USA Revised: January 2007 BASPCC01/07 S0107 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK      74146

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE - BUTALBITAL,
ASPIRIN,
CAFFEINE AND CODEINE PHOSPHATE CAPSULE
PHYSICIANS TOTAL CARE, INC.
----------
RX ONLY
DESCRIPTION
Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is
supplied in capsule form for
oral administration.
Each capsule contains the following active ingredients:
butalbital, USP ……………………..50 mg
aspirin, 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:
C
H N O molecular weight 224.26
Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic,
and anti-inflammatory. It has the
following structural formula:
C H O molecular weight 180.16
Caffeine (1,3,7-trimethylxanthine) is a central nervous system
stimulant. It has the following structural
formula:
11
16
2
3
9
8
4
C H N O molecular weight 194.19
Codeine phosphate
(7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol
phosphate (1:1)
(salt) hemihydrate) is a narcotic analgesic and antitussive. It has
the following structural formula:
C
H NO P anhydrous molecular weight 397.37
_Inactive Ingredients: _microcrystalline cellulose, pregelatinized
starch, talc. Gelatin capsules contain
D&C Yellow No.10, FD&C Blue No.1, FD&C Red No. 3, FD&C Yellow No. 6,
gelatin, titanium
dioxide. The capsules are printed with edible ink containing red iron
oxide.
CLINICAL PHARMACOLOGY
Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is
a combination drug product
intended as a treatment for tension headache.
Butalbital, Aspirin, and Caffeine Capsules, USP consists of a fixed
combination of caffeine 40 mg,
butalbital 50 mg, and aspirin 325 mg. The role each component plays in
the relief of the complex of
symptoms known as tension headache is incompletely understood.
Pharmacokinetics
Bioavailability: The bioavailability of the components of the fix