Consumer medicine information

Carboprost Dr. Reddy's

Carboprost

BRAND INFORMATION

Brand name

Carboprost Dr.Reddy's

Active ingredient

Carboprost

Schedule

SUMMARY CMI

CARBOPROST DR.REDDY'S

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. What is CARBOPROST DR.REDDY'S used for?

CARBOPROST DR.REDDY'S contains the active ingredient carboprost trometamol. CARBOPROST DR.REDDY'S is used to stop or treat bleeding that happens after a birth.

For more information, see Section 1. What is CARBOPROST DR.REDDY'S used for? in the full CMI.

2. What should I know before I use CARBOPROST DR.REDDY'S?

Do not use if you have ever had an allergic reaction to carboprost trometamol or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are breastfeeding.

For more information, see Section 2. What should I know before I use CARBOPROST DR.REDDY'S? in the full CMI.

3. How CARBOPROST DR.REDDY'S is given

CARBOPROST DR.REDDY'S is administered by healthcare professionals
It is given as an injection into a muscle.

Detailed instructions on administration of CARBOPROST DR.REDDY'S can be found in Section 3. How CARBOPROST DR.REDDY'S is given in the full CMI.

4. What should I know while using CARBOPROST DR.REDDY'S?

Things you should do	Remind any doctor, dentist or pharmacist you visit that you are using CARBOPROST DR.REDDY'S. A short-term fever may happen with this drug. Be sure you know when you need to call your doctor or get medical help if you get a fever after getting this drug.
Things you should not do	Do not take this medicine if you are allergic to any of the ingredients listed at the end of this leaflet.
Driving or using machines	Do not drive or operate any machinery if you feel tired or dizzy after using CARBOPROST DR.REDDY'S.
Looking after your medicine	This injection will be given to you in a healthcare setting. You will not store it at home.

For more information, see Section 4. What should I know while using CARBOPROST DR.REDDY'S? in the full CMI.

5. Are there any side effects?

For more information, including what to do if you have any side effects, see Section 5. Are there any side effects? in the full CMI.

FULL CMI

CARBOPROST DR.REDDY'S

Active ingredient(s): carboprost trometamol

Consumer Medicine Information (CMI)

This leaflet provides important information about using CARBOPROST DR.REDDY'S. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using CARBOPROST DR.REDDY'S.

Where to find information in this leaflet:

1. What is CARBOPROST DR.REDDY'S used for?
2. What should I know before I use CARBOPROST DR.REDDY'S?
3. How CARBOPROST DR.REDDY'S is given
4. What should I know while using CARBOPROST DR.REDDY'S?
5. Are there any side effects?
6. Product details

1. What is CARBOPROST DR.REDDY'S used for?

CARBOPROST DR.REDDY'S contains the active ingredient carboprost trometamol.

Carboprost trometamol belongs to a group of medicines called prostaglandins. Prostaglandins are produced naturally in your body and are very important for a variety of activities, including childbirth. After childbirth they make the womb contract and to help it stay contracted, which stops heavy bleeding from the womb. CARBOPROST DR.REDDY'S given after childbirth increases the contraction of your womb which helps to control bleeding after delivery.

2. What should I know before I use CARBOPROST DR.REDDY'S?

Warnings

Do not use CARBOPROST DR.REDDY'S if:

you are allergic to carboprost trometamol, or any of the ingredients listed in section 6, in particular benzyl alcohol which can cause problems in some people. See Section 4 of this leaflet for more details.

Symptoms of an allergic reaction may include:

shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body, skin rash, itching or hives.
you currently have an infection of your womb, ovaries or fallopian tubes (this may be causing pain in your pelvis or vaginal discharge).
you have any problems with your heart, lung, kidney or liver.
you are pregnant.

Talk to your doctor or nurse before you are given CARBOPROST DR.REDDY'S if you currently have, or have had in the past any of the following, as CARBOPROST DR.REDDY'S will have to be used more carefully:

lung disease, including asthma
high or low blood pressure (including high blood pressure in pregnancy)
heart disease or anaemia (low blood count)
kidney or liver disease (including jaundice)
glaucoma (raised pressure in your eyes)
diabetes or epilepsy
a caesarean section or any other operation on your womb

In very rare cases heart and circulation failure have been reported following the use of prostaglan dins (the active ingredient of this medicine).

It is possible that this medicine may lower the oxygen levels in your blood. If you have previously suffered from conditions affecting your heart and lungs your doctor will monitor you and may give you additional oxygen as necessary.

Your doctor may give you other medicines to reduce the side effects of being sick or having diarrhoea as these are the common side effects of all prostaglandins (the active ingredient of this medicine).

Raised temperature has been observed with treatment from CARBOPROST DR.REDDY'S. This will usually return to normal several hours after the last injection.

Other medicines and CARBOPROST DR.REDDY'S

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

Treatments that strengthen contraction of the womb, including oxytocin and ergometrine, can be affected by CARBOPROST DR.REDDY'S. Medical staff will watch over you very carefully if you have had these treatments as well as CARBOPROST DR.REDDY'S.

Use in Pregnancy and Breastfeeding

Carboprost Dr.Reddy's will only be given shortly after you have delivered your baby and not while you are still pregnant as it could put the embryo or foetus at risk.

It is not known if carboprost is excreted in human breast milk. As your own body produces prostaglandins during childbirth, carboprost is not expected to cause any harm to your baby.

CARBOPROST DR.REDDY'S contains benzyl alcohol.

This medicine contains 9.45 mg benzyl alcohol in each vial which is equivalent to 9.45 mg/ml. Benzyl alcohol may cause allergic reactions. Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children. Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

3. How CARBOPROST DR.REDDY'S is given

How much to take/use

This product should be used only in hospitals and clinics with specialised units for pregnancy and childbirth. Medical staff should be available in the hospital at all times. This product may be given by a doctor or a midwife. The staff will make sure that this medicine is used in the right way and at the right time. You should never be given CARBOPROST DR.REDDY'S while you are pregnant, only after the birth. It must never be given by injection into a vein.

It is given by injection deep into a muscle.
The first dose is usually 1 ml of solution (250 micrograms of carboprost). Your doctor may give you more doses of 1 ml if you need them. You should not have doses more often than once every 15 minutes. Usually you would have them less often, about once in one-and-a-half hours.
You should not be given more than 8 doses (2 mg of carboprost) altogether.

CARBOPROST DR.REDDY'S is not indicated for use in children.

If you are given more than you should be

If you get very bad sickness and diarrhoea, your doctor may delay the next injection of CARBOPROST DR.REDDY'S, or may not give you any more doses. Your doctor will treat the symptoms that the injection has caused.

If you continue to bleed

If you continue to bleed heavily after being given CARBOPROST DR.REDDY'S you may be given other medicines to help control the bleeding. Your doctor or midwife will be watching you closely to help them decide whether CARBOPROST DR.REDDY'S is working for you.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. What should I know while using CARBOPROST DR.REDDY'S?

Things you should do

Driving or using machines

Do not drive, use any tools or operate machinery soon after receiving CARBOPROST DR.REDDY'S as it may affect your ability to do so safely. CARBOPROST DR.REDDY'S may make you lose consciousness, feel dizzy or drowsy.

5. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Less serious side effects

Less serious side effects	What to do
diarrhoea nausea vomiting increased body temperature headache flushing hot flush chills coughing	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects	What to do
Allergy (hypersensitivity) Symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty breathing swelling of the face, lips, tongue or other parts of the body, skin rash, itching or hives	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

6. Product details

This medicine is only available with a doctor's prescription.

What CARBOPROST DR.REDDY'S contains

Active ingredient (main ingredient)	Carboprost
Other ingredients (inactive ingredients)	trometamol benzyl alcohol sodium chloride hydrochloric acid sodium hydroxide water for injections

Do not take this medicine if you are allergic to any of these ingredients.

What CARBOPROST DR.REDDY'S looks like

CARBOPROST DR.REDDY'S is supplied as a clear and colourless solution in a glass vial in packs of 10. (Aust R 387952).

Who distributes CARBOPROST DR.REDDY'S

Dr. Reddy's Laboratories (Australia) Pty Ltd.
Suite 3.03 Level 3, 390 St Kilda Road
Melbourne VIC 3004

This leaflet was prepared in May 2023.

Published by MIMS August 2024

BRAND INFORMATION

Brand name

Carboprost Dr.Reddy's

Active ingredient

Carboprost

Schedule

1 Name of Medicine

Carboprost (as trometamol).

2 Qualitative and Quantitative Composition

Each vial contains carboprost trometamol equivalent to 250 microgram carboprost.

Excipients with known effect.

Contains benzyl alcohol (see Section 4.4 Special Warnings and Precautions for Use).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection for single use only.
Carboprost Dr.Reddy's injection is a colourless, sterile aqueous solution for intramuscular administration.

4 Clinical Particulars

4.1 Therapeutic Indications

Carboprost Dr.Reddy's is indicated for the treatment of postpartum haemorrhage due to uterine atony which has not responded to conventional methods of management.

4.2 Dose and Method of Administration

Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
An initial dose of 250 microgram (1.0 mL) should be administered by deep intramuscular injection. If necessary, further doses of 250 microgram 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 should not exceed 2 mg (8 doses).
Product is for single use in one patient only. Discard any residue.

4.3 Contraindications

1. Hypersensitivity to carboprost trometamol or to any of the excipients (see Section 6.1 List of Excipients).
2. Acute pelvic inflammatory disease.
3. Patients with active cardiac, pulmonary, renal or hepatic disease.
4. Carboprost Dr.Reddy's is contraindicated in pregnancy.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Carboprost should be used by appropriately trained personnel in hospitals and clinics with specialised obstetric units. Carboprost, as with other potent oxytocic agents, should be used only with strict adherence to recommended dosages.
This preparation should not be used for the induction of labour.
Carboprost must not be given intravenously.
Very rare cases of cardiovascular collapse have been reported following the use of prostaglandins. This should always be considered when using carboprost.
Carboprost Dr.Reddy's contains benzyl alcohol which has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.
The preservative benzyl alcohol has been associated with serious adverse events, including the "gasping syndrome", and death in paediatric patients. The minimum amount of benzyl alcohol at which toxicity may occur is not known. The risk of benzyl alcohol toxicity depends on the quantity administered and the liver and kidneys' capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity. High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).
Carboprost should be used with caution in patients with a history of glaucoma or raised intra-ocular pressure, asthma, hypotension or hypertension, cardiovascular, renal or hepatic disease, anaemia, jaundice, diabetes or epilepsy.
During the clinical trials with carboprost, 5/115 (4%) patients had an increase in blood pressure reported as a side effect. The degree of hypertension was moderate. The cases reported did not require specific therapy for the elevated blood pressure.
Since prostaglandins may potentiate the effect of oxytocin, it is recommended that the use of these drugs simultaneously or in sequence should be carefully monitored.
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 carboprost can cause similar bone effects.
As with any oxytocic agent, carboprost should be used with caution in patients with previously compromised (scarred) uteri.

Use in patients with chorioamnionitis.

During the clinical trials with carboprost, chorioamnionitis was identified as a complication contributing to postpartum uterine atony and haemorrhage in 8/115 (7%) of cases, 3 of which failed to respond to carboprost. This complication during labour may have an inhibitory effect on the uterine response to carboprost similar to what has been reported for other oxytocic agents.

Use in patients with pre-existing cardio-pulmonary problems.

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

Use in hepatic impairment.

Carboprost should be used with caution in patients with a history of impaired liver function and is contra-indicated in patients with active liver disease.

Use in renal impairment.

Carboprost should be used with caution in patients with a history of impaired renal function and is contra-indicated in patients with active renal disease.

Use in the elderly.

No data available.

Paediatric use.

Safety and efficacy in paediatrics patients have not been established.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

As Carboprost Dr.Reddy's can potentiate the effect of other oxytocics, concomitant use is not recommended.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There are no clinical data on the effects of carboprost trometamol on human fertility.
Administration of carboprost at doses up to 3 times the expected maximum human dose (based on surface area) for 3 or 6 days prior to mating had no effect on male or female fertility in rats, although other carboprost-like drugs are known to disrupt fertility.
(Category D)
Administration of prostaglandins such as carboprost during pregnancy stimulates the uterus and may cause inability to sustain pregnancy and irreversible fetal damage or death. Carboprost is indicated in the postpartum period. It is not indicated for use during pregnancy.
Carboprost has been found to cross the placenta and distribute to the fetus in pregnant women. Any dose of carboprost that produces increased uterine tone could put the fetus at risk.
In animal studies, administration of carboprost for 3 or more days during gestation caused a high incidence of resorptions in rats and rabbits and embryotoxic effects in rats. The lowest dose of carboprost which caused these effects was approximately 6 and 36 times lower, in rats and rabbits respectively, than the recommended maximum dose in humans (based on surface area comparisons).
Administration of carboprost to rats for 7-8 days prior to delivery was associated with shortened gestation length, dystocia, increased incidence of still births and decreased offspring body weight. The lowest dose of carboprost which caused these effects was approximately 100 times lower than the recommended maximum dose in humans (based on surface area comparisons).
Carboprost Dr.Reddy's contains benzyl alcohol which can cross the placenta (see Section 4.4 Special Warnings and Precautions for Use).
It is not known if carboprost is secreted into breast milk, however, this possibility cannot be ruled out.
Administration of carboprost to rats during the pre- and post-natal period resulted in failure of dams to lactate. The lowest dose of carboprost which caused these effects was approximately 100 times lower than the recommended maximum dose in humans (based on surface area comparisons). The effect was reversible.
The relevance of these findings to lactation in humans treated with carboprost is unclear. However, based on plasma clearance rates it is recommended that breast feeding does not occur for at least 6 hours after administration.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.
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 Carboprost Dr.Reddy's does not affect their ability to drive or use machines.

4.8 Adverse Effects (Undesirable Effects)

The adverse effects of carboprost are generally transient and reversible on cessation of therapy.

Clinical trials.

The most frequent adverse effects observed with the use of carboprost in clinical trials (n = 448 patients) are related to its contractile effect on smooth muscle. In Study # 7055 (n = 115 patients) events occurring at an incidence > 1% were vomiting, diarrhoea and/or nausea (19%), temperature elevation (7%) and increased blood pressure (4%). In the post-marketing study (n = 333 patients) adverse events did not appear to be dose related and included diarrhoea (8.1%), vomiting (4.8%) and increased blood pressure (5.1%).
Other adverse effects reported rarely in clinical use include pulmonary oedema, diaphoresis, dizziness, asthma and wheezing.
Adverse effects are listed in Table 1 by body system:

Hyperthermia and flushing have been observed after intramuscular carboprost but, if not complicated by endometritis, temperature will usually return to normal within several hours of the last injection.

Post-marketing experience.

The following adverse events were identified from post-marketing experience:

Immune system disorders.

Hypersensitivity reactions (e.g. anaphylactic reaction, anaphylactic shock, anaphylactoid reaction, angioedema).

Endocrine disorders.

Thyrotoxic crisis.

Psychiatric disorders.

Anxiety, nervousness.

Nervous system disorders.

Syncope.

Cardiac disorders.

Palpitations.

Respiratory, thoracic and mediastinal disorders.

Choking sensation, epistaxis, dry throat.

Gastrointestinal disorders.

Retching.

Skin and subcutaneous tissue disorders.

Rash.

Musculoskeletal and connective tissue disorders.

Blepharospasm.

General disorders and administration site conditions.

Chest pain, asthenia, excessive thirst.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Treatment of overdosage must be symptomatic at this time, as clinical studies with prostaglandin antagonists have not progressed to the point where recommendations may be made. If evidence of adverse effects appears, the frequency of administration of carboprost should be decreased or administration discontinued.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Carboprost is a synthetic 15-methyl analogue of dinoprost (prostaglandin F2α). It is a uterine stimulant with a more prolonged action than dinoprost. When used in postpartum haemorrhage, it stimulates the uterus to contract in a manner similar to that normally observed in the uterus following delivery. The resulting myometrial contractions provide haemostasis at the site of placentation and hence prevent further blood loss. Whether or not this action results from a direct effect on the myometrium has not been determined with certainty at this time. The fundamental actions of prostaglandins include inhibition or stimulation of smooth muscle contraction and inhibition of the release of noradrenaline or modulation of its effects at neuroeffector sites. In addition to effects on the uterus, carboprost stimulates the smooth muscle of the gastrointestinal tract, which commonly results in vomiting or diarrhoea or both when used at recommended doses. It may cause a transient elevation of body temperature and transient bronchoconstriction.
At higher doses in both animals and humans, carboprost can increase blood pressure, possibly through the contraction of vascular smooth muscle.

Clinical trials.

Two open label clinical trials have been conducted to support the efficacy and safety of carboprost in the treatment of postpartum haemorrhage due to uterine atony and refractory to conventional therapeutic measures. The first was an uncontrolled, multicentre study in 115 patients with refractory postpartum haemorrhage conducted in the USA (Study # 7055). Carboprost was reported to achieve haemostasis, thus avoiding further intervention, such as surgery, in 87.8% of patients, with the majority of patients (73.3%) requiring only a single dose. Adverse events reported were dose related and not serious.
The second report relates to a post-marketing study conducted over 12 months at 14 centres in the USA. In this uncontrolled epidemiological study, a total of 333 patients were evaluated and carboprost was found to control the postpartum haemorrhage, thus avoiding surgical intervention in 83.8% of cases. 81.4% of patients required only a single dose of carboprost. Adverse events did not appear to be dose-related.

5.2 Pharmacokinetic Properties

Absorption.

Five women who had spontaneous vaginal deliveries (at term) were treated immediately post partum with a single intramuscular injection of 250 microgram carboprost. Peripheral blood samples were collected at several times during the four hours following treatment. The highest concentration was observed at 15 minutes in two patients (3009 and 2916 picogram/mL), at 30 minutes in two patients (3097 and 2792 picogram/mL) and at 60 minutes in one patient (2718 picogram/mL).

5.3 Preclinical Safety Data

Genotoxicity.

Carboprost showed no evidence for mutagenic activity in the AMES test or for clastogenic activity in a rat micronucleus test. However, the genotoxic potential of the human metabolites of carboprost was not assessed in these studies.

Carcinogenicity.

Long term studies have not been conducted to evaluate the carcinogenic potential of carboprost, nor has comprehensive battery of genotoxicity assays.

Teratogenicity.

Carboprost has been found to cross the placenta and distribute to the fetus in pregnant women. Any dose of carboprost that produces increased uterine tone could put the fetus at risk.
In animal studies, administration of carboprost for 3 or more days during gestation caused a high incidence of resorptions in rats and rabbits and embryotoxic effects in rats. The lowest dose of carboprost which caused these effects was approximately 6 and 36 times lower, in rats and rabbits respectively, than the recommended maximum dose in humans (based on surface area comparisons).

6 Pharmaceutical Particulars

6.1 List of Excipients

Trometamol, sodium chloride, benzyl alcohol (as preservative), sodium hydroxide and/or hydrochloric acid (for pH adjustment), water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store at 2 to 8°C (Refrigerate. Do not freeze).

6.5 Nature and Contents of Container

Carboprost Dr.Reddy's injection is available as 250 micrograms/1 mL packed in a 2 mL Type I clear glass vial, closed with a Teflon coated rubber stopper and an aluminium polypropylene flip-off seal.
Pack size: 10 vials.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Carboprost trometamol is the trometamol salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α. The chemical name is (15S)-9α, 11α, 15-trihydroxy-15-methylprosta-cis-5, trans-13-dienoic acid trometamol salt.

Chemical structure.

CAS number.

58551-69-2.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

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