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METAFLAM

Quick Overview

 Our aim is to reach out to the globe within shortest possible time frame. 


To promote this objective, not only we distribute and market our  Veterinary  range of products globally through our distribution channels but we also undertake ‘contract manufacturing’& ‘formulation development ’of our wide range of generic products such as Metflam which contains  Meloxicam BP. 1.5 mg.


This Metaflam contains same active ingredients as Metacam from Boehringer Ingelheim.


 

Metaflam Sup 32ml

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Details

Each ml contains:

Meloxicam BP.......1.5 mg

Aqueous base....q.s.

CHEMISTRY: 4-hydroq-2-methyl-N-(5-methyl-1,3-thiazol-2-y1)-2 H-1,2- benzothiazine-3-carboxamide 1,1-dioxide

CATEGORY: Analgesic, anti-inflammatory.

PHARMACOLOGY

PHARMACODYNAMICS:

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies have reported that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cycloonegenase-1 (COX-1).

PHARMACOKINETICS:

Meloxicam has nearly 100% bioavailability when administered orally with food. The terminal elimination half-life after a single dose is estimated to be approximately 24 hrs (+/-30%) regardless of route of administration. There is no evidence of statistically significant gender differences in drug pharnnacokinetics. Drug bioavailability, volume of distribution and total systemic clearance remain constant up to 5 times the recommended dose for use in dogs. However, there is some evidence of enhanced drug accumulation and terminal elimination half-life prolongation when dogs are dosed for 45 days or longer. Peak drug concentrations can be expected to occur within about 7.5 hrs after oral administration. Corresponding peak concentration is approximately 0.464 mcg/mL following a 0.2 mg/kg oral dose. The drug is 97% bound to canine plasma proteins.

INDICATIONS:

Meloxicam oral suspension is indicated for the control of pain and inflammation associated with osteoarthritis in dogs.

DOSAGE AND ADMINISTRATION:

Meloxicam oral suspension should be administered initially at 0.09 mg/lb (0.2 mg/kg) body weight only on the first day of treatment. For all treatments after day 1, meloxicam oral suspension should be administered once daily at a dose of 0.045 mg/lb (0.1 mg/ kg).

Directions for Administration:

Dogs under 10 pounds (4.5 kg)

Shake well before use, then remove cap. Particular care should be given with regard to the accuracy of dosing. To prevent accidental overdosing of small dogs, administer drops on food only, never directly into the mouth. Carefully measure suspension onto food to assure that the correct dose is given before presentation of the food to the dog. The syringe provided with the meloxicam concentration of 1.5 nng/nnL cannot be used to measure doses for dogs weighing less than 5 lbs (2.3 kg). For dogs less than 5 lbs (2.3 kg), meloxicam oral suspension can be given using the dropper bottle: one drop for each pound of body weight for the 1.5 nng/mL concentration (two drops for each kilogram of body weight), dropped directly onto the food. For dogs between 5 - 10 pounds, meloxicam oral suspension can be given by drops or by using the measuring syringe provided in the package (see dosing procedure below). The syringe fits on to the bottle and has a scale beginning at 5 lbs, designed to deliver the daily maintenance dose (0.05 mg/lb or 0.1 mg/kg). When using the syringe, the dog's weight should be rounded down to the nearest 5 pound increment. Replace and tighten cap after use.

Dogs over 10 pounds (4.5 kg)

Shake well before use then remove cap. Meloxicam oral suspension may be either mixed with food or placed directly into the mouth. Particular care should be given with regard to the accuracy of dosing. Meloxicann oral suspension can be given using the measuring syringe provided in the package (see dosing procedure below). The syringe fits on to the bottle and has a scale in pounds designed to deliver the daily maintenance dose (0.05 mg/lb or 0.1 mg/kg). When using the syringe, the dog's weight should be rounded down to the nearest 5 pound increment. Alternatively, meloxicam oral suspension can be given using the dropper bottle: one drop for each pound of body weight for the 1.5 mg/mL concentration (two drops for each kilogram of body weight). Replace and tighten cap after use.

 1.  Shake bottle well. Push down and unscrew bottle top. Attach the dosing syringe to the bottle by gently pushing the end on to the top of the bottle.

2.  Turn the bottle/syringe upside down. Pull the plunger out until the black line on the plunger corresponds to the dog's body weight in pounds.

3.  Turn the bottle right way up and with a twisting movement separate the dosing syringe from the bottle.

4.  Push the plungerto empty the contents of the syringe.

WARNINGS AND PRECAUTIONS:

Not for use in humans. Keep out of reach of children. Consult a physician in case of accidental ingestion by humans. For oral use in dogs only. As with any NSAID all dogs should undergo a thorough history and physical examination before the initiation of NSAID therapy.

Dogs with known hypersensitivity to meloxicam should not receive meloxicann oral suspension. Do not use in cats. Appropriate laboratory testing to establish hematological and serum biochemical baseline data is

signs of potential drug toxicity and be given client information sheet about meloxicam.

Precautions:

The safe use of meloxicam oral suspension in dogs younger than 6 months of age, dogs used for breeding, or in pregnant or lactating bitches has not been evaluated. Meloxicam is not recommended for use in dogs with bleeding disorders, as safety has not been established in dogs with these disorders. As a class, cyclooxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal and hepatic toxicity. Sensitivity to drug associated adverse events varies with the individual patient. Patients at greatest risk for renal toxicity are those that are dehydrated, on concomitant diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached. Since many NSAIDs possess the potential to produce gastrointestinal ulceration, concomitant use of meloxicam oral suspension with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided or closely monitored. Consider appropriate washout times when switching from corticosteroid use or from one NSAID to another in dogs. The use of concomitantly protein-bound drugs with meloxicann oral suspension has not been studied in dogs. Commonly used protein-bound drugs include cardiac, anticonvulsant and behavioral medications. The influence of concomitant drugs that may inhibit metabolism of meloxicam oral suspension has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy.

INTERACTIONS:

Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Anticoagulants: Because nonsteroidal anti-inflammatory drugs [NSAIDs] have been associated with inhibition of platelet aggregation and with the potential for gastrointestinal ulceration or bleeding, concurrent administration with an anticoagulant could increase the risk of adverse effects; however, studies in dogs have indicated that effects on thromboxane A2 [as measured by thromboxane B2] are minimal, making antiplatelet effects unlikely when administered at recommended dosages; also, it has been reported that no change in buccal mucosal bleeding time occurs in healthy dogs with a single 0.2 mg/kg dose.

Anti-inflammatory drugs, nonsteroidal (NSAID) or Corticosteroids: Concurrent administration of more than one NSAID or of corticosteroids with a NSAID may greatly increase the risk of adverse effects.

Diuretics: Animals on diuretic therapy could have an increased risk of renal toxicity with NSAID administration.

Nephrotoxic medications: NSAIDs have been associated with renal toxicity; therefore, administration with other nephrotoxic medications should be viewed with caution.

PREGNANCY AND LACTATION:

Pregnancy/Lactation

Dogs: The safety of administering meloxicann to dogs during breeding, pregnancy or lactation has not been studied.

ADVERSE DRUG REACTIONS:

In most cases, adverse effects were transient and disappeared after termination of treatment. In rare cases however, death has been associated with some of these adverse reactions. The following suspected adverse effects have been reported:

Gastrointestinal: Vomiting, diarrhea, inappetence, nnelena, hematemesis, ulceration.

Central Nervous System/Behavioral: Ataxia, seizures, sleepiness, hyperactivity, depression, trembling.

Renal: Elevated creatinine and BUN, acute renal failure.

Dernnatologic: Pruritus, eczema, focal alopecia, moist dermatitis (hot spots). Hypersensitivity: Urticaria, allergic dermatitis.

Hematologic: Immune mediated hemolytic anemia, immune mediated thrombocytopenia.

Hepatic: Elevated liver enzymes, jaundice.

Information for Dog Owners: Meloxicam, like other drugs of its class, is not free from adverse reactions. Owners should be advised of the potential for adverse reactions and be informed of the clinical signs associated with drug intolerance. Adverse reactions may include vomiting, diarrhea, decreased appetite, dark or tarry stools, increased water consumption, increased urination, pale gums due to anemia, yellowing of gums, skin or white of the eye due to jaundice, lethargy, incoordination, seizure, or behavioral changes. Serious adverse reactions associated with this drug class can occur without warning and in rare situations result in death (see Adverse Reactions). Owners should be advised to discontinue meloxicam and contact their veterinarian immediately if signs of intolerance are observed. The vast majority of patients with drug related adverse reactions have recovered when the signs are recognized; the drug is withdrawn and veterinary care if appropriate is initiated. Owners should be advised of the importance of periodic follow up for all dogs during administration of any NSAID.

OVERDOSAGE:

In case of overdosing, symptomatic treatment should be initiated.

PRESENTATION:

32 ml and 100 mI HDPE bottle with measuring syringe

 

 

 

 
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