Ambene parenteral amp #1

Ambene Parenteral Solution 200 mg/1 mL (2 mL Ampoule)

Composition:

• Active ingredients (per 2 mL ampoule):

• Phenylbutazone sodium – 400 mg

• Lidocaine hydrochloride – 4 mg

• Excipients: Sodium hydroxide, sterile water for injection.

Indications:

Used for symptomatic relief of pain and inflammation in the following acute conditions:

• Acute attack of ankylosing spondylitis (Bechterew’s disease)

• Acute exacerbation of chronic polyarthritis

• Acute gout attack

The injectable form of Ambene should be used only when oral administration is not feasible or has proven insufficient.

Dosage and Administration:

• At the onset of acute attacks (ankylosing spondylitis, rheumatoid arthritis, gout), administer one ampoule.

• Inject slowly and deeply into the muscle.

• To avoid local tissue irritation from the concentrated solution, the injection must be given carefully:

• Ensure the needle does not enter a blood vessel.

• Inject very slowly to prevent tissue damage and pain.

• Inject into a lying patient, always intramuscularly.

• Use a long syringe for overweight patients.

• Avoid injecting near or into nerves. Discontinue immediately if severe pain or numbness occurs during injection.

• Injection into the anterior muscle reduces the risk of nerve injury; caution is required when injecting lower muscle areas.

• Only a single injection per acute episode; subsequent treatment continues with tablets or suppositories.

Side Effects:

May include:

• Gastrointestinal issues: ulcers, perforation, gastrointestinal bleeding (especially in elderly patients), vomiting, nausea, diarrhea, constipation, dyspepsia, abdominal pain, melena, hematemesis, oral mucosal inflammation, colitis, Crohn’s disease

• Cardiovascular: edema, hypertension, cardiac failure, myocardial infarction

• Hematologic: anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis

• Infectious-like symptoms: high fever, sore throat, oral ulcers, flu-like manifestations, severe fatigue, epistaxis

• Others: headache, dizziness, fatigue, pulmonary edema, pancreatitis, salivary gland inflammation, oliguria, fluid retention (often in the calves), generalized weakness

• Injection site: accidental subcutaneous administration may cause fat necrosis; complex skin reactions like redness and blistering

• Allergic: rash, pruritus, thyroid swelling, anaphylactic signs (facial/lip/tongue/throat swelling, shortness of breath, arrhythmia, circulatory collapse up to shock)

• Hepatic: elevated liver enzymes, jaundice, hepatitis

• Nervous system: irritability, agitation, insomnia

Discontinue use immediately and consult a physician if any of the above symptoms occur.

Contraindications:

Ambene should not be used in cases of:

• Hypersensitivity to phenylbutazone, pyrazolone derivatives, or any excipient

• Aspirin or other NSAID-induced asthma, nasal swelling, or skin reactions

• Unknown hematologic or coagulation disorders

• Current or past peptic ulcers or gastrointestinal hemorrhage, perforation related to NSAID use

• Cerebral hemorrhage or other active bleeding

• Bleeding tendencies

• Severe renal or hepatic impairment

• Heart failure

• Pregnancy or breastfeeding

• Children and adolescents

Use in Pregnancy and Lactation:

Contraindicated in pregnant and breastfeeding women.

Driving and Machinery Use:

Patients should not drive or operate machinery due to side effects like fatigue and dizziness.

Storage:

Store in the original package, out of reach of children.