Malasiya Product

Larfix Tablets

Larfix Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:

When you should consult your doctor?

You should consult your doctor if you experience any of the following:
Usually the preparation is well tolerated. During a long-term usage of high doses there can be possible follow side effects:

GIT:
nausea, vomiting, heartburn, diarrhea.

CNS:
hyperexcitability of CNS, headache.

Urinary system:
formation of urinary, cystine and oxalate concernments.
Skin and subcutaneous tissue: allergic reactions.

Blood system:
It can cause erythrocyte hemolysis in patients with insufficiency of glucose-6-phosphatdehydrogenase of hematocytes.

What to do if you miss a dose?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Ascozin® increases salicylates (increases a risk of crystalluria), ethynilestradiol, benzylpenicillin and tetracyclines concentrations in blood, and decreases per oral contraceptives concentration in blood. It reduces anticoagulation effect of coumarin derivatives. It improves iron drugs absorption in intestine. It increases general clearance of ethyl alcohol. Quinolone drugs, calcium chloride, salicylate, corticosteroid decrease vitamin C reserve when used for a long term. Corticosteroids (cortisone and prednisolone), which are administered in concrete diseases (arthritis, bronchial astma etc), also reduce vitamin C and zinc levels.
Concurrent usage of ascorbic acid and deferoxamine enhances tissue toxicity of iron, especially in cardiac muscle that can cause decompensation of blood circulatory system. It can be used only in 2 hours after deferoxamine injection. A long-term administration of high doses in patients, who are treated by disulfiram, inhibits disulfamide-alcohol reaction.
High doses of the preparation decrease efficacy of tricyclic depressants.

What to do if you accidentally take too much (overdose) of the medicine?

Symptoms:
nausea, vomiting, intestine spasm, diarrhea; it is possible allergic reaction, kidney dysfunction, blood pressure increase, hyperexcitability of CNS, sleep disturbance.

Treatment:
It is symptomatic.

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication. For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

Store in a dry, protected from light place at a temperature not more than 25° C.
Keep it out of reach of children.

Drug Description

COMPOSITION:

Each film-coated tablet contains:
Lornoxicam………………..…………4/8 mg Additional ingredients:
Lactose, microcrystalline cellulose, polyvinyl pyrrolidone, croscarmellose sodium, magnesium stearate, opadry white 03F58750 and purified water


Indications and dosage.

INDICATIONS:
Short term treatment of mild to moderate pain associated with extra articular inflammation. Symptomatic treatment of pain and inflammation in osteoarthritis and rheumatoid arthritis.
DOSAGE:
Larfix film-coated tablets are supplied for oral administration with a sufficient quantity of liquid. Lornoxicam is not recommended for use in children (under 18 years). No special dosage modification is required for elderly patients, unless renal or hepatic function is impaired, in which case the daily dosage should be considered. For all patients the appropriate dosing regimen should be based upon individual response to treatment. Lornoxicam should be given in doses of 4 mg or 8 mg, and the daily dose should in general not exceed 16 mg..
Maximum daily dose should not exceed 16 mg per day.
For patients with mild and severe renal failure and severe liver failure recommended daily dose is 12 mg split into 2 – 3 intakes.

Side effects and drug interactions.

ADVERSE REACTIONS:

Approximately 16% of patients (in case of long term treatment 20 – 25%) can be expected to experience adverse reaction concerning the gastrointestinal tract, 5% concerning the general disorders and/or central nervous system disorders, and 2% concerning the skin. In common with other NSAIDs including oxicam the following undesirable effects may occur: - Gastrointestinal ulcerations with intestinal perforation, which may be severe,
- Duodenal ulcers, haematemesis and melaena,
- Possible onset of severe skin reactions and serious life threatening hypersensitivity reactions,
- In rare cases: interstitial nephritis, glomerulonephritis, renal medullary necrosis or nephrotic syndrome,
- Disturbances of blood count, blood dyscrasia, leukocytopenia.
Gastrointestinal disorders

Frequent (≥1% and <10%):
abdominal pain, diarrhoea, dyspepsia, nausea, vomiting. Infrequent (<1%): constipation, dysphagia, dry mouth, flatulence, gastritis, gastroesophageal reflux, peptic ulceration and/or gastrointestinal bleeding, stomatitis, haemorrhoidal bleeding. General disorders
Frequent: dizziness, headache Infrequent: insomnia, somnolence, malaise, weakness, flushing Skin and Subcutaneous Tissue Disorders
Infrequent: alopecia, dermatitis, pruritus, increased sweating, rash, urticaria, purpura, ecchymoses Haemopoietic Disorders Infrequent: thrombocytopenia, increased bleeding time, anaemia, decrease in erythrocytes, haemoglobin, leucocytes Cardiovascular Disorders
Infrequent: oedema, hypertension, palpitations, tachycardia, hypotension Neurological disorders
Infrequent: drowsiness, dizziness, vertigo, paraesthesia, tremor, taste perversion Respiratory Disorders Infrequent: dyspnoea, bronchospasm, cough, rhinitis Renal and Urinary disorders
Frequent: increase in blood urea nitrogen and creatinine levels Infrequent: micturition disorder Psychiatric disorders Infrequent: agitation, depression Hepato-biliary Disorders
Frequent: increase in serum transaminase levels, alkaline phosphatase level Infrequent: liver function abnormalities Musculoskeletal, Connective Tissue and Bone Disorders Infrequent: myalgia, leg cramps Disorders of the Eye
Infrequent: conjunctivitis, vision disorder Disorders of the Ear Infrequent: tinnitus Disorders of the Immune System
Infrequent: allergic reactions

Warnings and precautions

Special warnings and precautions for use:
For the following disorders, Lornoxicam should only be administered after careful risk benefit assessment. - Gastrointestinal ulceration and bleeding in medical history: Clinical monitoring at regular intervals is recommended. Patients developing peptic ulceration and/or gastrointestinal bleeding while taking Lornoxicam should discontinue drug administration and with appropriate therapeutic actions being taken. - Renal impairment
- Patients with mild renal impairment (Serum creatinine 150 - 300 μmol/L) should be monitored quarterly; patients with moderate renal impairment (Serum creatinine 300 – 700 μmol/L) should be monitored in 1 to 2 months intervals. Should renal function deteriorate during treatment Lornoxicam should be discontinued.
- Patients with blood coagulation disorders
Careful clinical monitoring and laboratory assessment is recommended. (eg. PTT). - Liver diseases (eg. liver cirrhosis) Clinical monitoring and laboratory assessment at regular intervals is recommended. (eg. liver enzymes).
- Long term treatment (longer than 3 months) Regular laboratory assessments of haematology (haemoglobin), renal functions (creatinine) and liver enzymes are recommended.
- Elderly patients (65 years or above) Monitoring of renal and hepatic function is recommended It is important to monitor renal function in patients
- Who are to undergo major surgery?
- With stressed renal function e.g. as a result of significant blood loss or severe dehydration
- With cardiac failure
- receiving concomitant treatment with diuretics
- receiving concomitant treatment with drugs that are suspected to or known to be able to cause kidney damage.
Concomitant treatment with NSAIDs and Heparin in the context of a spinal or peridural anaesthesia increase the risk of spinal/epidural hematoma.

Overdosage and Contraindications

Overdose:
At this time, there is no experience of overdose to permit definition of the consequence of an overdose, or to suggest specific managements. However, it can be expected that after an overdose with Lornoxicam, the following symptoms can be seen, nausea and vomiting, cerebral symptoms (dizziness, ataxia ascending to coma and cramps). Change of liver and kidney function, may be coagulation disorders. In the case of a real or suspected overdose, the medication should be withdrawn. Due to its short half-life, lornoxicam is rapidly excreted. Lornoxicam is not dialysable. No specific antidote is known to date. The usual emergency measures including gastric lavage should be considered. Lornoxicam can lead to diminished absorption of the preparation. Gastrointestinal disorders can for example be treated with a prostaglandin analogue or ranitidine.

CONTRAINDICATIONS:
- Those allergic to lornoxicam, or any of its excipients
- Those who has suffered hypersensitivity reactions (symptoms like asthma, rhinitis, angioedema or urticaria) to other non steroidal anti-inflammatory drugs, including acetylic salicylic acid.
- Patients with gastro-intestinal bleeding, cerebrovascular bleeding or other bleeding disorders
- Patients with active peptic ulceration or with a history of recurrent peptic ulceration
- Patients with severe liver impairment
- Patients with severe renal impairment (Serum creatinine > 700 μmol/L)
- Patients with severe thrombocytopenia
- Patients with severe heart insufficiency
- Elderly patients (>65 years) and weighing less than 50kg and undergoing acute surgery.
- Pregnancy or lactation
- Patients under 18 years of age, due to lack of clinical experience


Clinical pharmacology.

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics
.Lornoxicam is a non steroidal anti-inflammatory drug with analgesic properties and belongs to the class of oxicams. Lornoxicam's mode of action is partly based on inhibition of the prostaglandin synthesis (inhibition of the cyclooxygenase enzyme). The inhibition of cyclooxygenase does not result in an increase in leukotriene formation.The mechanism of the analgesic action of lornoxicam, as well as that of other NSAIDs, has not yet been fully determined.
Pharmacokinetics.
Lornoxicam is absorbed rapidly and almost completely from the gastrointestinal tract. Maximum plasma concentrations are achieved after approximately 1 to 2 hours. The absolute bioavailability (calculated on AUC) of Larfix film-coated tablets is 90-100%. No first-pass effect was observed. The mean elimination half-life is 3 to 4 hours. Lornoxicam is found in the plasma in unchanged form and as its hydroxylated metabolite. The hydroxylated metabolite exhibits no pharmacological activity. The plasma protein binding of lornoxicam is 99% and not concentration dependent. Lornoxicam is metabolized completely, and approximately 2/3 is eliminated via the liver and 1/3 via the kidneys as inactive substance. Lornoxicam is metabolized by cytochrome P450 2C9. Due to genetic polymorphism slow and rapid metabolisers exist for this drug, which could result in markedly increased plasma levels of lornoxicam in slow metabolisers. Simultaneous intake of lornoxicam with meals reduced Cmax by approximately 30%. Tmax was increased from 1.5 to 2.3 hours. The absorption of lornoxicam (calculated on AUC) can be reduced up to 20%. Simultaneous intake with antacids has no effect on the pharmacokinetics of lornoxicam. In elderly subjects the clearance is reduced by 30 to 40%. Apart from this reduced clearance there is no significant change in the kinetic profile of lornoxicam in elderly patients, or in patients with mild hepatic or kidney dysfunction..
Shelf-life:
24-months

Storage:
Store below 30°C. Keep all medicines out of reach of children.

Package:
10 tablets in blister. 3 or 10 blisters in carton pack.

Conditions of supply:
By prescription.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare
D-158A, OKHLA,INDUSTRIAL AREA,
PHASE-I, NEW DELHI,
Pin 110020
INDIA
Tel: 011-41005147, 011-40514919
Fax: +91-11-40527575