BARALGAN-D
Manufacturer Details
SANOFI AVENTIS
SANOFI INDIA LTD
SANOFI HOUSE, CTS NO 117-B
L&T BUSINESS PARK
SAKI VIHAR ROAD, POWAI
ANDHERI EAST, MUMBAI 400072
Compositions:
Drotaverine 40mg/80mg tablets,
Drotaverine 40mg per 2ml injection,
|
Strength
|
Rate
|
Packing Style
|
|
40mg
|
48.75
|
10s tablets
|
|
80mg
|
54.70
|
2ml injection
|
|
40mg per 2ml
|
13.88
|
2ml injection
|
List of Related Indications:
List Of Drugs:
- Drotaverine hcl - Antispasmodics- (FDC- List ) (Sep 2008)
Indication Type Description:
Pharmacology/ Pharmacokinetics
Drug Interaction:
Can be concurrently used with analgesics, antimuscarrinics or benzodiapines with beneficial effect.
It may attentuate the clinical effects of levodopa when given concurrently.
Indication:
U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
196. Drotaverine 15-09-08
Aceclofenac (80mg + 100mg) tablets
For the treatment of adult patients with muscular pain
associated with spasm
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Drotaverine + Aceclofenac 15-09-2008
80mg+ 100mg Tablets
For the treatment of adult patients with muscular pain associated
with spasm
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Drotaverine 80mg + 15-09-2008
Aceclofenac 100mg tablet
For the treatment of adult patient with muscular pain associated
with spasm
Relief of smooth muscle spasm due to gastritis
Adverse Reaction:
Drotavarine is generally well tolerated and free from side effects, addiction, dryness of mouth, blurring of vision and blood dyscrasias.
It does not cause gastric irritation or other gastrointestinal effects.
Safety in pregnancy, children, hypertension, glaucoma, and prostatic hypertrophy.
Contra-Indications:
Severe renal/hepatic/cardiac dysfunction. Hypersensitivity to the drug.
Special precaution:
In severe renal/hepatic/cardiac dysfunction drotaverine administration is not recommended.
Dosages/ Overdosage Etc:
Indication-
Relief of smooth muscle spasm due to gastritis
Dosage-
Usual dose is 40-80mg thrice daily.
In children, doses should be adjusted to age and body weight 1-6 yrs age group: 20mg three to four times a day.
Over 6 yrs: 40mg thrice daily. In peptic ulcer drotaverine can be combined with antimuscarrinics to acheive the optimal effect.
Pharmacology/ Pharmacokinetics:
Pharamacology:
Drotaverine is an isoquinolone antispasmodic recently introduced in India. Drotaverine produces its effect by inhibiting phosphodiesterase- IV which is specific for smooth muscle. It has a rapid and direct action on the smooth muscle. It acts at the cyclic site correcting cyclic AMP and calcium imbalance and thereby relieves the smooth muscle spasm.
Pharmacokinetics:
Following oral dosing the adsorption of drotaverine is rapid from the small intestine with an absorption half-life of about 12 min. The T max is about 45- 60 minutes.
The primary elimination half-life, following IV use is 2.4 hrs and terminal elimination half-life is 16 hrs. The pharmacokinetics of drotaverine is not affected by the route of administration.
Interaction with Food:
Not indicated
Pregnancy and lactation:
Pregnancy-
The therapeutic use of drotaverine in the last 30 yrs has not shown any adverse effect in pregnancy.
Drotaverine is considered safe and effective when used as recommended during pregnancy.
