Espironolactona AC Farma may be available in the countries listed below.
Spironolactone is reported as an ingredient of Espironolactona AC Farma in the following countries:
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Merzin may be available in the countries listed below.
Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Merzin in the following countries:
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PMS-Anagrelide may be available in the countries listed below.
Anagrelide hydrochloride (a derivative of Anagrelide) is reported as an ingredient of PMS-Anagrelide in the following countries:
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Clognil may be available in the countries listed below.
Clopidogrel hydrogen sulfate (a derivative of Clopidogrel) is reported as an ingredient of Clognil in the following countries:
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Baclofen USP is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid.
Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The structural formula is represented below:
Baclofen Tablets, USP 10 mg and 20 mg contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose and pregelatinized starch.
The precise mechanism of action of Baclofen is not fully known. Baclofen is capable of inhibiting both monosynaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Although Baclofen is an analog of the putative inhibitory neurotransmitter gamma-amino-butyric acid (GABA), there is no conclusive evidence that actions on GABA systems are involved in the production of its clinical effects. In studies with animals, Baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression. Baclofen is rapidly and extensively absorbed and eliminated. Absorption may be dose-dependent, being reduced with increasing doses. Baclofen is excreted primarily by the kidney in unchanged form and there is relatively large intersubject variation in absorption and/or elimination.
Baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
Patients should have reversible spasticity so that Baclofen treatment will aid in restoring residual function.
Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
The efficacy of Baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.
Hypersensitivity to Baclofen.
Safe use of Baclofen in children under age 12 has not been established, and it is, therefore, not recommended for use in children.
Because of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system effects of Baclofen may be additive to those of alcohol and other CNS depressants.
Baclofen should be used with caution where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function.
In patients with epilepsy, the clinical state and electroencephalogram should be monitored at regular intervals, since deterioration in seizure control and EEG have been reported occasionally in patients taking Baclofen.
It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.
A dose-related increase in incidence of ovarian cysts and a less marked increase in enlarged and/or hemorrhagic adrenal glands was observed in female rats treated chronically with Baclofen.
Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients that were treated with Baclofen for up to one year. In most cases these cysts disappeared spontaneously while patients continued to receive the drug. Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population.
The most common is transient drowsiness (10–63%). In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving Baclofen compared to 36% of those in the placebo group. Other common adverse reactions are dizziness (5–15%), weakness (5–15%) and fatigue (2–4%). Others reported:
Neuropsychiatric: Confusion (1–11%), headache (4–8%), insomnia (2–7%); and, rarely, euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure.
Cardiovascular: Hypotension (0–9%). Rare instances of dyspnea, palpitation, chest pain, syncope.
Gastrointestinal: Nausea (4–12%), constipation (2–6%); and, rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool.
Genitourinary: Urinary frequency (2–6%); and, rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria.
Other: Instances of rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion.
Some of the CNS and genitourinary symptoms may be related to the underlying disease rather than to drug therapy. The following laboratory tests have been found to be abnormal in a few patients receiving Baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.
Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression and seizures.
In the alert patient, empty the stomach promptly by induced emesis followed by lavage. In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis). Maintain adequate respiratory exchange, do not use respiratory stimulants.
The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40–80 mg daily).
The following dosage titration schedule is suggested:
5 mg t.i.d. for 3 days
10 mg t.i.d. for 3 days
15 mg t.i.d. for 3 days
20 mg t.i.d. for 3 days
Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.).
The lowest dose compatible with an optimal response is recommended. If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS Abrupt Drug Withdrawal ).
Baclofen Tablets, USP 10 mg are off-white, scored, oval-shaped tablets debossed "2265" on one side and debossed "V" on the reverse side. Supplied in bottles of 10, 30, 90, 100, 500 and 1000.
Baclofen Tablets, USP 20 mg are off-white, scored, capsule-shaped tablets debossed "2266" on one side and debossed "V" on the reverse side. Supplied in bottles of 10, 30, 100, 500 and 1000.
Dispense in a tight container with child-resistant closure.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811
8181162
R6/11-R3
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA077156 | 08/30/2005 | |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA077068 | 08/30/2005 | |
| Labeler - Qualitest Pharmaceuticals (011103059) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Vintage Pharmaceuticals-Charlotte | 151228897 | MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Vintage Pharmaceuticals-Huntsville | 825839835 | MANUFACTURE | |
Mupirocine may be available in the countries listed below.
Mupirocine (DCF) is known as Mupirocin in the US.
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Glossary
| DCF | Dénomination Commune Française |
In some countries, this medicine may only be approved for veterinary use.
Ketamine hydrochloride (a derivative of Ketamine) is reported as an ingredient of Ketaject in the following countries:
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Sefrad may be available in the countries listed below.
Cefradine is reported as an ingredient of Sefrad in the following countries:
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Areston may be available in the countries listed below.
Diclofenac potassium salt (a derivative of Diclofenac) is reported as an ingredient of Areston in the following countries:
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Clarithromycin Sandoz may be available in the countries listed below.
Clarithromycin is reported as an ingredient of Clarithromycin Sandoz in the following countries:
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Lansopril may be available in the countries listed below.
Lansoprazole is reported as an ingredient of Lansopril in the following countries:
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Gastroshield may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Omeprazole is reported as an ingredient of Gastroshield in the following countries:
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Gliclafin-M may be available in the countries listed below.
Gliclazide is reported as an ingredient of Gliclafin-M in the following countries:
Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Gliclafin-M in the following countries:
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Cantharone Liq 0.7% may be available in the countries listed below.
Cantharidin is reported as an ingredient of Cantharone Liq 0.7% in the following countries:
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Betablock may be available in the countries listed below.
Atenolol is reported as an ingredient of Betablock in the following countries:
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Hyaluope may be available in the countries listed below.
Hyaluronic Acid sodium salt (a derivative of Hyaluronic Acid) is reported as an ingredient of Hyaluope in the following countries:
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