KARLOX (Meloxicam USP)

Meloxicam is well absorbed from the gastrointestinal tract, which reflected by a high absolute bioavailability of 89% following oral administration (Tablet). Following single dose administration of meloxicam, mean maximum plasma concentrations achieved within 2 hours for the suspension and within 5-6 hours with solid oral dosage forms (tablets)

5. With multiple dosing, steady state conditions were reached within 3 to days. Once daily dosing leads to drug plasma concentrations with a relatively small peak-trough fluctuation in the range of 0.4-1.0 µg/ml for 7.5 mg doses and 0.8-2.0 µg/ml for 15 mg dossa, respectively (Cmin and Cmax at steady state, respectively). Distribution: Meloxicam is very strongly bound to plasma proteins, essentially albumin (99%). Meloxicam penetrates into synovial fluid to give concentrations approximately half of those in plasma

Meloxicant undergoes extensive hepatic biotransformation.The major metabolite, 5

carboxy meloxicam (60% of dose), is formed by oxidation of an Intermediate metabolite 5- hydroxymethylmeloxicam, which is also excreted to a lesser extent (9% of dose). In vitro studies suggest that CYP 209 plays an important role in this metabolic pathway, with a minor contribution from the CYP 3A4 isoenzyme. The patient’s peroxidase activity is probably responsible for the other two matabolites, which account for 16% and 4% of the administered dose respectively.

Elimination:

Meloxicam is excreted predorninantly in the form of metabolites and occurs to equal extents in urine and faeces. Less than 5% of the daily dose is excreted unchanged in faeces, while only traces of the parant compound are excreted in urine.

The mean elimination half-life is about 20 hours, Total plasma clearance amounts on average 8 mL/min. Linearity/non-linearity

Meloxicam demonstrates linear pharmacokinetics in the therapeutic dose range of 7.5 mg 15 mg. following per oral or intramuscular adminiştration.

Indications:

Short-Term Symptomatic Treatment of Exacerbations of Osteoarthritis Long Term Symptomatic Trealment of Rheumatoid Arthritis or Ankylosing Spondylitis.

Dosage: Adult: ORAL: Osteoarthritis:

7.5 mg tablet once daily, of necessary to max 15 mg once daily

Rheumatoid arthritis, ankylosing spondylitis: 15 mg tablet ornice daily

Children:

Rallef of pain and inflarnymation in juvenile idiopathic arthritis and other musculoskeletal disorders in children intolerant to other NSAIDs: ORAL

12-18 yr and body-weight under 50 kg.

unusual bruising or bleeding, chest pain, palpitations, fast heartbeat, swelling in extremities, blood in urine/stool/mouth/vomitus, acute fatigue, skin rash, itching, blister, lever, changes in hearing, ringing in eans,

yellowing of skin or eyes, difficulty in speaking.

Pregnancy: Risk cannot be ruled out.

Lactation: Contraindicated or not recommended.

Contraindications:

Active peptic ulcer, GI bleeding, aspirin/anti-inflammatory induced allergy, severa hepatic or renal failure, severe CHF, active inflammatory

bowel disease, cerebrovascular bleeding, bleeding disorder, Treatment of pain after CABG

Precaution: Congestive heart failure, liver cirrhosis, nephrotic syndrome, ranal

failure, hypovolemia, Gi upset, hypertension, ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, other cardiovascular risk factors Elderly.

Interactions:

Anticoagulants, lithium, IUDs, methotrexate, cholestyramine, diuretics, cyclosporin, antihypertensives, thrombolytics, other NSAIDS. tacrolinius, antiplatelets, SSRIs, corticosteroids.

Adverse effects:

Also for the perforation, ulceration, bleeding or upset, monitor patient. Muco- cutaneous reactions including pruritus, rash, urticarial, angioedema,

photosensitivity, erythema multiforme, Stevens-Johnson syndrome. CNS or cardiovascular effects, blood dyscrasias, transient disturbances in liver tests. Headache, Glupset, fluid and electrolyte disturbances.

Dosage:

As directed by the physician:

Instructions:

Store at room temperature (15°C-25°C). Protect from sunlight. Keep

away from the reach of children

Presentation:

Karlox 7.5mg tablets: Pick of 10’s.

Karlox 15mg tablets: Pack of 10’s.

خوراک ڈاکٹر کی ہدایت کے مطابق استعمال کریں۔

ہدایات دور کو کمرے کے درجہ حرارت (1500 سے 25 ) پر رکھیں۔ روشنی، دھوپ اورنگی سے بچائیں۔ بچوں کی بھی ہے اور رگیں ۔

صرف رجسٹر ڈ ڈاکٹر کے نسخہ پر فر وخت کریں۔

Manufactured by:

KARSONS PHARMACEUTICALS

Plot No. 01, Street No. SS-3, National Industrial Zone Rawat Rawalpindi-Pakistan