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Drug Details

Hemabate Sterile Solution

• Drug Class Description
  Prostaglandins.
• Generic Name
  Carboprost
• Presentation
  Colourless, sterile, aqueous solution for intramuscular injection.
• Description
  Each 1 ml contains carboprost tromethamine equivalent to carboprost 250 micrograms
• Indications
  Treatment of post-partum haemorrhage due to uterine atony and refractory to conventional methods of treatment with oxytocic agents and ergometrine used either alone or in combination. Conventional therapy should usually consist of 0.5 - 1 mg ergometrine with up to 50 units of oxytocin infused intravenously over periods of time from 20 minutes to 12 hours. The dosage and duration of administration should reflect the seriousness of the clinical situation.
• Adult Dosage
  

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

  An initial dose of 250 micrograms (1.0 ml) of Hemabate should be administered as a deep intramuscular injection.

  If necessary, further doses of 250 micrograms may be administered at intervals of approximately 1.5 hours. In severe cases the interval between doses may be reduced at the discretion of the attending physician, but it should not be less than 15 minutes. The total dose of Hemabate should not exceed 2 mg (8 doses).

  Elderly :	Not applicable
  Children :	Not applicable

• Contra Indications
  

  1. Hemabate should not be used where the patient is sensitive to carboprost tromethamine or any of the excipients.

  2. Acute pelvic inflammatory disease.

  3. Patients with known active cardiac, pulmonary, renal, or hepatic disease.

• Special Precautions
  

  Hemabate should be used by medically trained personnel and is available only to hospitals and clinics with specialised obstetric units where 24 hour resident medical cover is provided. Hemabate, as with other potent oxytocic agents, should be used only with strict adherence to recommended dosages.

  This preparation should not be used for induction of labour.

  Hemabate must not be given intravenously.

  Special caution is necessary in patients with history of asthma, hypo- or hypertension, cardiovascular, renal, or hepatic disease, glaucoma or raised intra-ocular pressure, anaemia, jaundice, diabetes, or epilepsy.

  Benefit/risk ratio should be assessed in patients with cardiovascular disease (risk of decreased blood pressure up to cardiovascular collapse, bradycardia), and in patients (possibility of decreased pulmonary blood flow and increased arterial pulmonary pressure).

  Very rare cases of cardiovascular collapse have been reported following the use of prostaglandins. This should always be considered when using Hemabate.

  Decreases in maternal arterial oxygen content have been observed in patients treated with carboprost tromethamine. A causal relationship to carboprost tromethamine has not been established, however, it is recommended that patients with pre-existing cardio-pulmonary problems receiving Hemabate are monitored during treatment and given additional oxygen if necessary.

  As with any oxytocic agent, Hemabate should be used with caution in patients with previously compromised (scarred) uteri.

  Prior treatment with, or concomitant administration of anti-emetics and antidiarrhoeal drugs significantly reduces the very high incidence of the gastrointestinal side effects common to all prostaglandins. Their use should be considered an integral part of the management of patients.

  Transient pyrexia that may be due to hypothalamic thermoregulation has been observed after intramuscular Hemabate. Temperature elevations exceeding 1.1 °C were observed in approximately one-eighth of patients who received the recommended dosage regimen but if not complicated by endometritis, the temperature elevation will usually return to normal within several hours of the last injection.

  Animal studies lasting several weeks at high doses have shown that prostaglandins of the E and F series can induce proliferation of bone. Such effects have also been noted in newborn infants who have received prostaglandin E₁ during prolonged treatment. There is no evidence that short-term administration of Hemabate can cause similar bone effects.

• Interactions
  

  As Hemabate can potentiate the effect of other oxytocics, concomitant use is not recommended.

• Adverse Drug Reactions
  

   

  The table below lists the adverse effects identified through clinical trials and post-marketing surveillance by System Organ Class (SOC) and frequency. Within each frequency grouping, adverse events are presented in order of decreasing seriousness. Frequencies are defined as: very common ( 1/10), common ( 1/100 to < 1/10), uncommon (1/1000 to < 1/100), or not known (cannot be estimated from the available data).

  The adverse effects of Hemabate are generally transient and reversible on discontinuation of therapy. The most frequent adverse reactions observed are related to its contractile effect on smooth muscles.

   

  MedDRA System Organ Class	Frequency	Undesirable Effects
  Infections and Infestations	Uncommon	Septic shock, Urinary tract infection
  Endocrine disorders	Not Known	Thyrotoxic crisis
  Psychiatric disorders	Uncommon	Sleep disorder
  	Not Known	Anxiety, Nervousness
  Nervous system disorders	Common	Headache*
  	Uncommon	Vasovagal symptoms, Dizziness*, Dystonia, Paraesthesia, Somnolence, Dysgeusia
  	Not Known	Syncope
  Eye disorders	Uncommon	Vision blurred, Eye pain
  Ear and labyrinth disorders	Uncommon	Vertigo, Tinnitus
  Cardiac disorders	Uncommon	Tachycardia
  	Not Known	Palpitations
  Vascular disorders	Common	Flushing, Hot flush, Chills
  	Uncommon	Hypertension
  Respiratory, thoracic and mediastinal disorders	Common	Cough
  	Uncommon	Asthma, Respiratory distress, Dyspnoea, Hyperventilation*, Wheezing, Hiccups
  	Not Known	Bronchospasm, Pharyngeal oedema, Choking sensation, Epistaxis, Dry throat, Upper respiratory tract infection
  Gastrointestinal disorders	Very common	Diarrhoea*, Nausea*, Vomiting*
  	Uncommon	Haematemesis, Abdominal pain upper, Dry mouth
  	Not Known	Retching
  Skin and subcutaneous tissue disorders	Uncommon	Hyperhidrosis
  	Not Known	Rash
  Musculoskeletal and connective tissue disorders	Uncommon	Torticollis, Back pain, Myalgia,
  	Not Known	Muscle spasms, Blepharospasm
  Reproductive system and breast disorders	Common	Uterine haemorrhage, Retained placenta or membranes, Endometritis*
  	Uncommon	Uterine rupture, Uterine cervical laceration, Pelvic pain*, Breast tenderness
  	Not Known	Uterine disorder
  General disorders and administration site conditions	Uncommon	Lethargy, Chest discomfort, Injection site pain
  	Not Known	Chest pain, Asthenia, Thirst
  Investigations	Very common	Body temperature increased

  * Events reported for both intramuscular and intra-amniotic routes of administration are marked with an asterisk. All other events were reported only for the intramuscular route.