Felgin 20 Piroxicam Capsules

Felgin®-20 CAPSULES
PIROXICAM 20mg CAPSULES

COMPOSITION

Each FELGIN-20 Capsule contains 20mg piroxicam.

Sugar free

 

PHARMACOLOGICAL CLASSIFICATION

A. 3. 1 Anti Rheumatics (Anti-inflammatory agents)

 

PHARMACOLOGICAL ACTION

FELGIN has analgesic, anti-inflammatory and antipyretic properties, and is used in the treatment of rheumatoid arthritis and other rheumatic disorders. Piroxicam acts as an inhibitor of prostaglandin biosynthesis.

FELGIN is completely absorbed after oral administration: peak concentrations in plasma occur within two to four hours. Neither food nor antacids alter the rate or extent of absorption.

After absorption, piroxicam is extensively (99%) bound to plasma proteins, and has a long plasma half-life of approximately thirty-five to forty-five hours. At steady state, (e.g. after seven to ten days) concentrations of piroxicam in plasma and synovial fluid are approximately equal.

Piroxicam is metabolized in the liver by hydroxylation of the pyridyl ring of the piroxicam side chain followed by conjugation with glucuronic acid and urinary elimination. Less than 10% of the drug is excreted in the urine unchanged.

 

INDICATIONS

FELGIN is indicated for a variety of conditions requiring anti-inflammatory and/or analgesic activity, such as rheumatoid arthritis, osteo-arthritis (arthrosis, degenerative joint disease), ankylosing spondylitis, acute musculoskeletal disorders and acute gout.

 

CONTRA-INDICATIONS

FELGIN should not be used in those patients who have previously shown a hypersensitivity to the drug and patients who have hepatic dysfunction. FELGIN should be used with caution in patients with a history of gastro-intestinal haemorrhage, ulcers or aspirin sensitivity.

 

WARNINGS

Use in children:

FELGIN is not recommended for children.

 

INTERACTIONS

FELGIN should not be used in patients on coumarin-type anticoagulants.

FELGIN increases plasma lithium levels.

 

PREGNANCY AND LACTATION

FELGIN should not be used by patients who are pregnant.

The safety of FELGIN use during pregnancy or during lactation has not yet been established. FELGIN inhibits prostaglandin synthesis and release by an effect on prostaglandin biosynthetase. This effect has been associated with an increased incidence of dystocia and delayed parturition in pregnant animals when drug administration was continued into late pregnancy.

Regular use of NSAIDs during the third trimester of pregnancy may result in premature closure of the foetal ductus arteriosus in utero and possibly in persistent pulmonary hypertension of the newborn. The onset of labour may be delayed and its duration increased.

 

DOSAGE AND DIRECTIONS FOR USE

Rheumatoid arthritis, osteo-arthritis (arthrosis, degenerative joint disease), ankylosing spondylitis:

The usual daily dose for the relief of signs and symptoms of rheumatoid arthritis or osteroarthritis is 20 mg given in single or divided doses. Since steady state concentrations in plasma are not reached for seven to ten days, maximal therapeutic responses should not be expected for two weeks. Long-term administration of doses higher than 30 mg carries an increased risk of gastrointestinal side-effects.

Acute musculoskeletal disorders:

Therapy should be initiated within 40 mg daily for the first two days, given in single or divided doses. For the remainder of the seven to fourteen day treatment period, the dose should be reduced to 20mg daily.

Acute Gout:

Therapy should be initiated by a single oral dose of 40 mg followed on the next four to six days by 40 mg given in a single or divided daily dosage. FELGIN is not indicated for the long-term, management of gout.

 

SIDE-EFFECTS AND SPECIAL PRECAUTIONS

In view of the product’s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.

Gastrointestinal symptoms are the most commonly encountered side-effects. Long-term administration of doses higher than 30 mg daily carries an increased risk of gastrointestinal side-effects.

Peptic ulceration and gastrointestinal bleeding have been reported with FELGIN. Drug administration should be closely supervised in patients with a history of upper gastro-intestinal disease.

Other than the gastrointestinal symptoms, oedema, mainly ankle oedema, has been reported. Routine ophthalmoscopy and slit-lamp examination have revealed no evidence of ocular changes.

Changes in different liver function parameters have been observed. Some patients may develop increased serum transaminase levels during treatment with FELGIN.

Care should be exercised with the use of FELGIN in patients with renal dysfunction.

Blood urea nitrogen elevation has been observed in some patients. These elevations are not progressive over the course of treatment with FELGIN, a plateau being reached which returns to or towards baseline levels if treatment is stopped. The rise in blood urea nitrogen is not associated with elevations in serum creatinine. FELGIN decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind.
Dermal hypersensitivity reactions, usually in the form of skin rash, have been reported. Stevens-Johnson syndrome may develop.

Decreases in haemoglobin and haematocrit, independent of gastro-intestinal bleeding, have occurred. Thrombocytopenia and non-thrombocytopenic purpura (Henoch-Schnlein), aplastic anaemia, leucopenia and eosinophilia have been reported, and constitute indications for immediate withdrawal of FELGIN.

It should be assumed that FELGIN will precipitate bronchoconstriction in those patients who are hypersensitive to aspirin. Central nervous system effects such as dizziness, headache, somnolence and vertigo have been reported.

 

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

In the event of overdosage with FELGIN, supportive and symptomatic therapy is indicated.

 

IDENTIFICATION

FELGIN 20 mg Capsules: Opaque maroon capsules.

 

PRESENTATION

FELGIN 20mg Capsules: Securitainers of 100 capsules.

 

STORAGE INSTRUCTIONS

Store below 25o C.

Protect from light. Keep out of reach of children.

NAFDAC REGISTRATION NUMBERS: 04-3906

 

Manufactured by

YANGZHOU NO. 3 PHARMACEUTICAL LTD.

YILING, JIANGSU, JIANGSU, CHINA

 

Marketed by

JUBILEE AND ASSOCIATE INDUSTRIES LTD.

20 BARIKISU IYEDE STREET, ONIKE YABA, LAGOS

Micronac SR Aceclofenac Sustained Released Tablets

Micronac-SR
Aceclofenac Sustained Release Tablets 200 mg

 

COMPOSITION

Each film-coated sustained-release tablet contains:
Aceclofenac BP 200 mg

 

CHEMISTRY

It is a Phenylacetic acid derivative [[[2-[(2,6 Dichlorophenyl)amino]Phenyl]acetyl]oxy]acetic acid.

 

PHARMACOLOGICAL CATEGORY

Non Steroidal Anti-inflammatory Drug

 

PHARMACOLOGICAL PROPERTIES

The mode of action of aceclofenac is largely based on the inhibition of prostaglandin synthesis. Aceclofenac is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandins. The drug inhibits synthesis of the inflammatory cytokines interleukin (IL)-1 and tumor necrosis factor and prostaglandin E2 (PGE2) production. Effects on cell adhesion molecular from neurophils have also been noted. In vitro data indicate inhibition of cyclooxygenase (Cox)-1 and 2 by aceclofenac in whole blood assays, with selectivity for Cox-2 being evident. Aceclofenac has shown stimulatory effects on cartilage matrix synthesis that may be linked to the ability of the drug to inhibit IL-1 activity. In vitro data indicate stimulation by the drug of synthesis of glycosaminoglycan in osteoarthritic cartilage. There is also evidence that aceclofenac stimulates the synthesis of IL-1 receptor antagonist in human articular chondrocytes subjected to inflammatory stimuli and that 4’-hydroxyacelofenac has chondroprotective properties attributable to suppression of IL-1 mediated promatrix metalloproteinase production and proteoglycan release.

 

PHARMACOKINETIC

Aceclofenac is rapidly and completely absorbed after oral administration, peak plasma concentrations are reached 1 to 3 hours after an oral dose. The drug is highly protein bound (7.99%). The presence of food does alter the extent of absorption of aceclofenac but the absorption rate is reduced. The plasma concentration of aceclofenac was approximately twice that in synovial fluid after multiple doses of the drug in patient with knee pain and synovial fluid effusion. Aceclofenac is metabolized to a major metabolite, 4-hydroxyaceclofenac and to a number of other metabolites including 5-hydroxyaceclofenac, 4’-hydroxydiclofenac, diclofenac and 5-hydroxydiclofenac. Renal excretion is the main route of elimination of aceclofenac with 70 to 80% of an administered dose found in the urine, mainly as the glucuronides of aceclofenac and its metabolites of each dose of aceclofenac, 20% is excreted in the faeces. The plasma elimination half-life of the drug is approximately 4 hours.

 

INDICATION

For the relief of pain and inflammation in both acute and chronic pain like osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, dental pain, post-traumatic pain, low back pain, gynaecological pain etc.

 

CONTRAINDICATIONS

Hypersensitive to the drugs (may precipitate attacks of asthma, bronchospasm, acute rhinitis or urticaria), GI bleeding moderate to severe renal impairment, last three months of pregnancy.

 

UNDESIRABLE EFFECTS

Aceclofenac is well tolerated, with most adverse events being minor and reversible and affecting mainly the GI system. Most common events include dyspepsia (7.5%), abdominal pain (6.2%), nausea (1.5%), diarrhea (1.5%), flatulence (0.8%), gastritis (0.6%), constipation (0.5%), vomiting (0.5%), ulcerative stomatitis (0.1), pancreatitis (0.1%). Although the incidence of gastro intestinal adverse events with aceclofenac was similar to those of comparator NSAIDS in individual clinical trials, withdrawal rates due to these events were significantly lower in aceclofenac than with ketoprofen and tenoxicam. Other adverse effect, which is not common such as dizziness (1%), vertigo (0.3%), and rare cases: par aesthesia and tremor.

 

PRECAUTIONS/WARNINGS

Cautiously administer to patients with gastro-intestinal disease, history of peptic ulceration, cerebro-vascular bleeding, ulcerative colitis, Crohn’s disease, SLE, porphyria, hematopoietic-or coagulation-disorders. The dose should be reduced in patients with mild to moderate impairment of hepatic, renal or cardiac functional impairment. The use of NSAIDs may result in deterioration of renal function and fluid retention.

 

PREGNANCY AND LACTATION

Pregnancy: There is no information on the use of aceclofenac during pregnancy. Aceclofenac should not be administered during pregnancy unless there are compelling reasons to do so. The lowest effective dose should be administered.

Lactation: There is no information on the secretion of aceclofenac in breast milk. The use of aceclofenac should therefore be avoided during lactation unless potential benefits to the mother outweigh the possible risks to the children.

 

DRUG INTERACTIONS

Aceclofenac may increase the plasma concentration of lithium & digoxin, concomitant use with diuretics may inhibit the activity of diuretics. Serum potassium should be monitored when used with potassium sparing diuretics. The activity of anticoagulants may be enhanced when used concomitantly with aceclofenac. Convulsion may occur due to interaction between quinolones and NSAIDs.

 

DOSAGE AND ADMINISTRATION

The usual dose of aceclofenac is 200 mg given twice daily by mouth, one tablet in the morning and one in the evening. There is no evidence that the dosage of aceclofenac needs to be modified in patients with mild renal impairment, but as with other NSAIDS caution should be exercised.

Adults: 200 mg orally b.i.d. Aceclofenac can be taken before or after food.

Children: There is no clinical data on the use of aceclofenac in children.

Hepatic insufficiency: Dosage reductions are recommended in patients with hepatic impairment, with a suggested initial dosage of 100 mg/day.

 

OVERDOSAGE, SYMPTOMS AND ANTIDOTE

There are no human data available on the consequences of aceclofenac overdosage. The symptoms could be: Nausea, vomiting, stomach pain, dizziness, somnolence and headache. Treatment: If required, gastric lavage, charcoal in repeated doses. Antacids when necessary and other symptomatic treatment.

 

STORAGE

Store below 30°C. Keep out of reach of children.

 

DATE OF PUBLICATION

August 2011

NAFDAC Reg. No. : B4-0219

 

Manufactured by

MICRO LABS LIMITED-UNIT III

R.S. No. 63/3&4, Thiruvandar Koil,

Pondicherry-605 102. INDIA.

Sivoloratadine Loratadine Tablets USP

SIVOLORATADINE

Loratadine Tablets USP 10 mg

 

COMPOSITION

Each SIVOLORATADINE tablet contains 10 mg Loratadine USP.

 

PHARMACOLOGICAL CLASSIFICATION

A.5.7.1 Antihistaminics.

 

PHARMACOLOGICAL ACTION

Loratadine is a second generation histamine (H1)-receptor antagonist

Loratadine exerts its action by competing with histamine for H1-receptor sites on effector cells. It prevents but does not reverse, responses mediated by histamine.

Loratadine does not cross the blood-brain barrier to any extent.

Pharmacokinetics

After oral administration loratadine is well absorbed from the gastrointestinal tract and peak plasma concentrations are reached within 1.5 hours. Ingestion of food may enhance absorption of loratadine. Loratadine undergoes extensive first pass metabolism via the cytochrome P450 system.

The major metabolite, desloratadine, is active. Loratadine is 97% protein bound, while desloratadine is less extensively protein bound (73 % to 77 %). The mean elimination half life for loratadine and desloratadine are 8.4 and 28 hours, respectively.

 

INDICATIONS

SIVOLORATADINE is indicated for the symptomatic relief of seasonal allergic rhinitis and chronic urticaria.

 

CONTRAINDICATIONS

Hypersensitivity to SIVOLORATADINE or to any of the ingredients in the preparation.

Cross sensitivity to other antihistamines.

Porphyria.

 

WARNINGS

Safety of SIVOLORATADINE in the elderly has not been established.

Safety of SIVOLORATADINE in children under two years of age has not been established.

SIVOLORATADINE should be used with caution in patients with:

Severe liver impairment, as reduced clearance of loratadine may occur. Dosage adjustment may be needed (See “DOSAGE AND DIRECTIONS FOR USE”).

Renal impairment -A lower starting dose should be used. In patients with chronic renal impairment (creatinine clearance of 30 mL/minute or less), both oral bioavailability and peak plasma concentration of loratadine may be increased. However, the elimination half-lives of loratadine and its active metabolite appear to be similar to those in individuals with normal renal function.

SIVOLORATAOINE may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other nervous system depressants (e.g. sedative, and tranquillisers). Caution should be used when driving a motor vehicle or operating machinery or performing potentially dangerous tasks, where loss of concentration may lead to accidents.

 

INTERACTIONS

Concomitant use of SIVOLORATADINE with inhibitors of the cytochrome P450 enzyme system; such as cimetidine, ketoconazole; clarithromycin and erythromycin, may increase the plasma concentration of SIVOLORATADINE.

 

PREGNANCY AND LACTATION

Safety and efficacy in pregnancy and lactation have not been established.

Loratadine and its metabolites have been detected in breast milk. Small amounts of SIVOLORATADINE entering breast milk may cause drowsiness or excitement in Infants.

 

DOSAGE AND DIRECTIONS FOR USE

Children 2 to 12 years of age:

Body weight lass than or equal to 30 kg: 5 mg (½ tablet) once daily.

Body weight more than 30 kg: 10 mg (1 tablet) once daily.

Adults and children over 1 years of age:

10 mg (1 tablet) once daily.

Adults with severe liver function impairment:

Initial dose is 5 mg (½ tablet) once daily or 10 mg (1 tablet) on alternate days.

Use of SIVOLORATADINE should be limited to 14 days.

 

SIDE-EFFECTS AND SPECIAL PRECAUTIONS

Side-effects:

Immune system disorders:

Less frequent: Allergic reactions, anaphylaxis.

Neuropsychiatric system disorders:

Frequent: Headache, somnolence, nightmares.

Less frequent: Sedation, nervousness, confusion, fatigue, convulsions, increased appetite or loss of appetite, abnormal coordination, and tremor.

Disorders of the special senses:

Less frequent: Ringing or buzzing in the ears and blurred vision.

Cardiovascular system disorders:

Less frequent: Cardiac arrhythmias, palpitations, tachycardia, and oedema.

Gastrointestinal system disorders:

Frequent: Dry mouth, gastrointestinal disorders, such as nausea and gastritis.

Less frequent: Constipation, diarrhoea.

Hepatobiliary system disorders:

Less frequent: Abnormal hepatic function, hepatitis or cholestasis.

Skin and subcutaneous tissue disorders:

Less frequent: Rash, increased sweating, photosensitivity.

The following side-effects have been reported and frequencies are unknown:

Alopecia.

Renal and urinary system disorders:

Less frequent: Difficult or painful urination.

Reproductive system and breast disorders:

Less frequent: Early menses.

 

Special Precautions

SIVOLORATADINE should be discontinued prior to skin tests using allergen extracts, as it may inhibit the cutaneous histamine response, thus producing false-negative results.

SIVOLORATADINE should be discontinued at least 48 hours before such tests.

SIVOLORATADINE should be used with caution in patients using other medication metabolised by the cytochrome P450 system and/ or when the following medical conditions exist:

Emphysema, prostatic hypertrophy, narrow-angle glaucoma, cardiovascular disorders, epilepsy and during acute attacks of asthma.

 

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

(See “SIDE-EFFECTS AND SPECIAL PRECAUTIONS”).

Symptoms of overdose

Tachycardia, somnolence and headaches have been reported. In children, extrapyramidal manifestations and palpitations have been reported.

Treatment of overdose:

Treatment is symptomatic and supportive. After overdosage of SIVOLORATADINE, the stomach should be emptied immediately by inducing emesis or by gastric Iavage. Administration of activated charcoal after emesis may be useful in preventing absorption of SIVOLORATADINE. Saline cathartics may be of value to rapidly dilute bowel contents. SIVOLORATADINE is not cleared by haemodialysis.

 

IDENTIFICATION

White to off white colour round shape uncoated tablets having both side plain.

 

PRESENTATION

Alu-Alu Blister packs of 10 tablets. Such 10 blister packed in one carton with pack insert.

 

STORAGE INSTRUCTIONS

Store in cool and dry place, protect from light.

 

KEEP OUT OF REACH OF CHILDREN.

 

Mfg. Lic. No.: G/25/1749 

NAFDAC No.: B4-0088

 

Manufactured in India by

Globela Pharma Pvt. Ltd.

357, G.I.D.C., Sachin Surat -394 230,

Gujarat (India)

http://www.globelapharma.com

 

Sole Agent

Adpharm Pharmaceuticals Industries Limited

No 60. Ajao Road, Surulere,

Lagos State, Nigeria.