Carboprost

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

Studies in animals have shown reproductive toxicity and any dose which produces increased uterine tone could put the embryo or foetus at risk.

There are no data on the excretion into breast milk for carboprost tromethamine.

Fertility

There are no clinical data on the effects of carboprost on fertility.

No studies on the effects on the ability to drive and use machines have been performed.

There have been reports of undesirable effects such as syncope, dizziness and somnolence which could impair the ability to drive or use machines.

Therefore patients should refrain from driving until they know that Hemabate does not affect their ability to drive or use machines.

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), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), or not known (cannot be estimated from the available data).

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

In patients studied, approximately two-thirds (66%) experienced vomiting and diarrhoea, approximately one-third (33%) had nausea, one-eighth (12%) had a temperature increase greater than 1.1°C, and one-fourteenth (7%) experienced flushing.

Infections and Infestations

Uncommon: Septic shock, Urinary tract infection

Common: Endometritis*

Immune system disorders

Not Known: Hypersensitivity reactions† (e.g. Anaphylactic reaction, Anaphylactic shock, Anaphylactoid reaction, Angioedema)

Endocrine disorders

Not Known: Thyrotoxic crisis†

Psychiatric disorders

Uncommon: Sleep disorder

Not Known: Anxiety†, Nervousness†

Nervous system disorders

Common: Headache*

Uncommon: Syncope vasovagal, Dizziness*, Dystonia, Paraesthesia, Somnolence, Dysgeusia, Lethargy

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

Uncommon: Uterine rupture, Uterine cervical laceration, Pelvic pain*, Breast tenderness

Not Known: Uterine disorder

General disorders and administration site conditions

Uncommon: Chest discomfort, Injection site pain

Not Known: Chest pain†, Asthenia†, Excessive 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.
^† Identified from post-marketing experience