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Name:Synalgos
Manufacturer:Caraco Pharma Inc.
Category:Prescription Marketed Drugs


SYNALGOS  - dihydrocodeine bitartrate, aspirin and caffeine capsule 
Caraco Pharma Inc.

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DESCRIPTION

Each Synalgos-DC capsule contains 16 mg drocode (dihydrocodeine) bitartrate (Warning–may be habit-forming), 356.4 mg aspirin, and 30 mg caffeine.

The inactive ingredients present are alginic acid, cellulose, D&C Red 28, FD&C Blue 1, gelatin, iron oxides, stearic acid, and titanium dioxide.

CLINICAL PHARMACOLOGY

Dihydrocodeine is a semisynthetic narcotic analgesic, related to codeine, with multiple actions qualitatively similar to those of codeine; the most prominent of these involve the central nervous system and organs with smooth-muscle components. The principal action of therapeutic value is analgesia.

Synalgos-DC also contains the nonnarcotic antipyretic-analgesic, aspirin.

INDICATIONS AND USAGE

For the relief of moderate to moderately severe pain.

CONTRAINDICATIONS

Hypersensitivity to dihydrocodeine, codeine, or aspirin.

WARNINGS

Salicylates should be used with extreme caution in the presence of peptic ulcer or coagulation abnormalities.

Drug Dependence

Dihydrocodeine can produce drug dependence of the codeine type and therefore has the potential of being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of dihydrocodeine, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic-containing medications. Like other narcotic-containing medications, dihydrocodeine is subject to the provisions of the Federal Controlled Substances Act.

Usage in Ambulatory Patients

Dihydrocodeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. The patient using Synalgos-DC should be cautioned accordingly.

Interactions with other Central Nervous System Depressants

Patients receiving other narcotic analgesics, general anesthetics, tranquilizers, sedative-hypnotics, or other CNS depressants (including alcohol) concomitantly with Synalgos-DC may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.

Usage in Pregnancy

Reproduction studies have not been performed in animals. There is no adequate information on whether this drug may affect fertility in human males and females or has a teratogenic potential or other adverse effect on the fetus.

Usage in Children

Preparations containing aspirin should be kept out of the reach of children. Synalgos-DC is not recommended for patients 12 years of age and under. Since there is no experience in chil­dren who have received this drug, safety and efficacy in children have not been established.

PRECAUTIONS

Synalgos-DC should be given with caution to certain patients, such as the elderly or debilitated.

Drug Interactions

The CNS-depressant effects of Synalgos-DC may be additive with that of other CNS depressants. See “WARNINGS.”

Aspirin may enhance the effects of anticoagulants and inhibit the uricosuric effects of uricosuric agents.

Geriatric Use

Clinical studies of Synalgos-DC did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects.

In general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

The most frequently observed reactions include lightheadedness, dizziness, drowsiness, sedation, nausea, vomiting, constipation, pruritus, and skin reactions.

DOSAGE AND ADMINISTRATION

Dosage should be adjusted according to the severity of the pain and the response of the patient. Synalgos-DC is given orally. The usual adult dose is two capsules every 4 hours as need­ed for pain.

HOW SUPPLIED

Synalgos®-DC Capsules are blue and gray, marked “CP” and “419”, supplied in:


Bottles of 100 capsules; NDC 49708-419-88
 
Store at room temperature, approx. 25°C (77°F). Keep tightly closed.
 
Dispense in tight container.

Manufactured by:                                                                                                      C.S. No.:8002T01

Mikart, Inc.                                                                                                                  Rev. 10/09

Atlanta, Georgia 30318                                                                                             Code 990B00

 

Distributed by:

Caraco Pharmaceutical Laboratories, Ltd.

1150 Elijah McCoy Drive

Detroit, MI 48202

www.caraco.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49708-419-88

100 Capsules

Synalgos®-DC

(dihydrocodeine bitartrate, aspirin, and caffeine capsules)

Each capsule contains: 16 mg drocode (dihydrocodeine) bitartrate (Warning–may
be habit-forming), 356.4 mg aspirin, and 30 mg caffeine.

SEALED FOR YOUR PROTECTION

Rx Only

Caraco Pharma, Inc.

Synalgos

SYNALGOS 
dihydrocodeine bitartrate, aspirin and caffeine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49708-419
Route of Administration ORAL DEA Schedule CIII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIHYDROCODEINE BITARTRATE (DIHYDROCODEINE) DIHYDROCODEINE BITARTRATE 16 mg
ASPIRIN (ASPIRIN) ASPIRIN 356.4 mg
CAFFEINE (CAFFEINE) CAFFEINE 30 mg
Inactive Ingredients
Ingredient Name Strength
ALGINIC ACID  
POWDERED CELLULOSE  
D&C RED NO. 28  
FD&C BLUE NO. 1  
GELATIN  
FERROSOFERRIC OXIDE  
STEARIC ACID  
TITANIUM DIOXIDE  
Product Characteristics
Color BLUE, GRAY Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code CP;419
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49708-419-88 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011483 12/30/2008

Labeler - Caraco Pharma Inc. (831527945)
Registrant - Mikart, Inc. (030034847)
Establishment
Name Address ID/FEI Operations
Mikart, Inc. 030034847 MANUFACTURE

Revised: 12/2009 Caraco Pharma Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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