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Aminophylline Injection BP

( Our Equivalent Generics )

Aminophylline Injection BP

Compositions:
Each ml contains Aminophylline BP 25 mg

Pharmacological classification & ATC Classification:
R03DA05 - aminophylline ; Belongs to the class of xanthines. Used in the systemic treatment of obstructive airway s.

Pharmacology:
Aminophylline is a combination of theophylline and ethylenediamine. Ethylenediamine is inactive; it increases the solubility of theophylline in water. Theophylline relaxes bronchial smooth muscle. Suggested mechanisms are an increase in intracellular cAMP through inhibition of phosphodiesterase; receptor antagonism, prostaglandin antagonism and effects on intracellular calcium.
Absorption: Rate of absorption delayed by food.
Distribution: Crosses the placenta and enters breast milk.
Metabolism: Undergoes hepatic metabolism.
Excretion: Via urine.

Indications:
Aminophylline is a complex of theophylline and ethylenediamine and is given for its theophylline activity to relax smooth muscle and to relieve bronchial spasm.

Aminophylline Injection is indicated for relief of bronchospasm associated with asthma and in chronic obstructive pulmonary .

Dosage & administration:
Intravenous
Acute severe bronchospasm

Adult: Loading dose: 5 mg/kg (ideal body weight) or 250-500 mg (25 mg/ml) by slow inj or infusion over 20-30 min. Maintenance infusion dose: 0.5 mg/kg/hr. Max rate: 25 mg/min.

Child: Loading dose: same as adult dose. Maintenance dose: 6 mth-9 yr: 1 mg/kg/hr and 10-16 yr: 0.8 mg/kg/hr.

Elderly: Dose reduction may be ncessary.

Hepatic impairment: Dose reduction may be ncessary.

Special Populations: Reduce maintenance dose in patients with cor pulmonale, heart failure or liver and in elderly. Increase maintenance dose for smokers.

Incompatibility: Incompatible with metals.

Contraindications:
Aminophylline injection should not be used in patients hypersensitive to ethylenediamine or those allergic to the theophyllines, caffeine or theobromine.

Aminophylline should not be administered concomitantly with other xanthine drugs. When therapeutic doses of Aminophylline and/or theophylline are administered simultaneously by more than one route or in more than one preparation, the hazard of serious toxicity is increased.

The use of Aminophylline IV in children under 6 months of age is not generally recommended.

The use of Aminophylline is contra-indicated in patients with acute porphyria.

Overdosage:
Symptoms may include agitated maniacal behavior, frequent vomiting, extreme thirst, slight fever, tinnitus, palpitation and arrhythmias. Treatment is usually supportive and withdrawal of the drug. Restoration of fluid and electrolyte balance is necessary.

Precautions:
Neonates, elderly, lactation, pregnancy, cardiac/hepatic s, peptic ulceration, hyperthyroidism, hypertension, epilepsy, heart failure, chronic alcoholism, acute febrile illness.

Side Effects:

Nausea, vomiting, abdominal pain, diarrhoea, headache, insomnia, dizziness, anxiety, restlessness; tremor, palpitations.

Potentially Fatal: Convulsions, cardiac arrhythmias, hypotension and sudden death after too rapid IV injection.

Pregnancy & Lactation:
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Storage:
Store below 25°C

Packing presentations:
(Also can be packed according to customer’s requirement)
10 ml Vials containing Aminophylline BP 25 mg/ml &
20 ml Vials containing Aminophylline BP 25 mg/ml


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Injection
( Our Equivalent Generics )
Compositions:
Each ml contains:
/Dipyrone 0.5 g

Pharmacological classification & ATC Classification:
Analgesics (Non-Opioid) & Antipyretics

Pharmacology:
It inhibits the synthesis of prostaglandins D and E resulting in analgesic, anti-inflammatory and antipyretic effects. It also has the potential for causing agranulocytosis.
Absorption: Rapidly hydrolysed in gastric juice to active metabolite 4-methyl-amino-antipyrine.
Distribution: Metabolites are distributed into breast milk.
Excretion: Mostly excreted in the urine as metabolites.
Indications:
As an Analgesic /Dipyrone Injection, by intravenous administration, is indicated for the relief of severeand acute pain when oral treatment is not feasible or suitable, as in post-traumatic orpost-surgical pain, biliary or renal colic, and pain associated with malignant s.Intravenous administration of dipyrone should be carried out slowly over a period ofat least 5 minutes, followed by reasonable clinical observation. Intramuscular administration of dipyrone for relief of pain is not recommended. However, if medical circumstances require such administration, all due precautions should be exercised to permit reasonable clinical observation. As an Antipyretic /Dipyrone Injection, by intramuscular administration, is indicated to lower temperature in life-threatening situations, when this cannot be achieved by other means. patients in critical condition may also be treated in non-hospital environment, under close medical supervision.

Dosage & administration:
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Adults and Adolescents Over 14 Years of Age Intravenous Administration as an Analgesic 1 g (2 ml), administered by slow injection, up to 4 times daily. In severe pain, 2.5 g (5 ml) may be administered twice daily (the maximum daily dosage is 5 g).Intramuscular Administration as an Antipyretic2.5 g (5 ml), to be repeated only if deemed necessary. Infants and Children Use of dipyrone is not recommended in infants under 3 months of age or5 kg/body weight. In infants 3-12 months, /Dipyrone Injection should be administered by the intramuscular route only. In older children, the injection may be administered by eitherthe intramuscular or intravenous routes. Dosage guidelines for the administration of /Dipyrone Injection as an analgesic and/or antipyretic, in infants over 3 months of age and in children, are presented in the table below:

Age Smallest Maximum
Single Dosage Daily Dosage
3-5 months 0.1 ml I.M. only 4 x 0.2 ml
6-11 months 0.1 ml I.M. only 4 x 0.3 ml
1-2 years 0.2 ml I.M./I.V. 4 x 0.4 ml
3-4 years 0.2 ml I.M./I.V. 4 x 0.6 ml
5-7 years 0.4 ml I.M./I.V. 4 x 0.8 ml
8-11 years 0.5 ml I.M./I.V. 4 x 1.0 ml
12-14 years 0.8 ml I M/ I.V. 4 x 1.6 ml

Contraindications:
Known hypersensitivity to dipyrone or to pyrazolone derivatives or to any other ingredient of the preparation. Pregnancy and breastfeeding. Acute porphyria. Genetic deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD). History of blood dyscrasias or acute bone marrow suppression

Interactions:
Dipyrone/ : Concurrent use of dipyrone and may cause hypothermia; therefore combined therapy with these two drugs should be avoided. Dipyrone/Cyclosporin: Dipyrone may cause a reduction in cyclosporin blood levels, byan unknown mechanism.

Dipyrone/ Alcohol: Concurrent administration is not recommended in patients who react to small quantities of (flush, lacrimation and sneezing), since these patients may be more prone to allergic reactions to dipyrone. Dipyrone/Anticoagulants: Because of possible thrombocytopenia appearing as an adverse reaction of dipyrone, caution is required when dipyrone is administered to patients on anticoagulant therapy.

Precautions:
Careful inquiry should be made concerning previous hypersensitivity reactions of the patients to drugs and food. Red coloration may appear in urine with acid pH; it may be due to an exceedingly small quantity of a metabolite (rubazonic acid).
Caution should be exercised when dipyrone is used in patients with hepatic or renal disorders

Warning:
When using parenteral dipyrone, special consideration should be given to thepossible risk of life-threatening complications resulting from "shock syndrome".It should be remembered that the risk of shock is much greater with parenteraladministration than with oral administration.
Careful monitoring is warranted in patients with high fever. Rare cases of agranulocytosis, as a hypersensitivity reaction, have been reported. The appearance of symptoms indicative of agranulocytosis, such as high fever, pain in throat, buccal ulceration, tiredness, and weakness, warrants immediate discontinuation of the drug, and an urgent blood count determination. Special caution is required in patients who may be more prone to hypersensitivity reactions, as in patients with bronchial asthma and chronic urticaria. As with other pyrazolone derivatives, cutaneous allergic reactions may appear suchas urticaria and maculopapular eruption. Exceptionally, they may be severe enoughand manifested by epidermal necrolysis (Stevens -Johnson syndrome or Lyell'ssyndrome), in which case immediate discontinuation of treatment is imperative. /Dipyrone Injection contains sodium dithionite as an antioxidant preservative. As withother sulfites, sodium dithionite may cause allergic-type reactions in certain susceptible patients, including anaphylactic symptoms and life-threatening, or less severe, asthmatic episodes. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic patients.

Side Effects:
The most serious adverse reactions to dipyrone are "shock syndrome", andagranulocytosis (see also Warnings). Allergic Anaphylactic shock (see Warnings). Agranulocytosis has rarely been reported. It is an immuno-allergic adverse reaction lasting at least 1 week. Agranulocytosis is unpredictable, not dose-related and may occur even after a single dose. Dermatological reactions (see Warnings).Hematological Rarely agranulocytosis, anemia, leucopenia and thrombocytopenia, have been reported. Renal Isolated cases of acute renal insufficiency or interstitial nephropathy have been reported. Other Drowsiness, tiredness, and headache have been reported with dipyroneadministration. Hypotension has been reported following intravenous administration of dipyrone. Nausea, vomiting, gastric irritation and xerostomia have been described with oral and parenteral dipyrone administration

Pregnancy & Lactation:
Read Contraindications

Storage:
Store below 25°C

Packing presentations:
(Also can be packed according to customer’s requirement)
Ampoule of 2 ml/ vial of 30 ml



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