Promethazine hydrochloride Injection USP 25mg/ml
- Name of the medicinal product
Promethazine hydrochloride 25mg/ml Solution for Injection USP Taj Pharma.
Promethazine hydrochloride 50mg/ml Solution for Injection USP Taj Pharma.
- Qualitative and quantitative composition
Each ampoule contains 25mg/ml of the active substance Promethazine hydrochloride.
Each ampoule contains 50mg/ml of the active substance Promethazine hydrochloride.
For a full list of excipients, see section 6.1.
- Pharmaceutical form
Solution for injection.
- Clinical particulars
4.1 Therapeutic indications
As symptomatic treatment for allergic conditions of the upper respiratory tract and skin including allergic rhinitis, urticaria and anaphylactic reactions to drugs and foreign proteins.
Sedation and treatment of insomnia in adults.
As an adjunct in preoperative sedation in surgery and obstetrics.
As a paediatric sedative.
4.2 Posology and method of administration
Route of administration: Intramuscular or intravenous (after dilution)
The usual dose is 25 – 50 mg by deep intramuscular injection, or, in emergency, by slow intravenous injection after dilution of the 2.5% solution to 10 times its volume with water for injections immediately before use.
Maximum parenteral dose 100 mg.
Elderly: No specific dosage recommendations.
Children:6.25 – 12.5 mg for children from 5 – 10 years by deep intramuscular injection. Not for use in children under 2 years of age (see section 4.3).
4.3 Contraindications
Promethazine hydrochloride should not be used in patients in coma or suffering from CNS depression of any cause.
Promethazine hydrochloride should not be given to patients with a known hypersensitivity to promethazine or to any of the excipients.
Promethazine is contraindicated for use in children less than two years of age because of the potential for fatal respiratory depression..
Promethazine hydrochloride should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously.
4.4 Special warnings and precautions for use
Promethazine hydrochloride may thicken or dry lung secretions and impair expectoration. It should therefore be used with caution in patients with asthma, bronchitis or bronchiectasis.
Use with care in patients with severe coronary artery disease, narrow angle glaucoma, epilepsy or hepatic and renal insufficiency.
Caution should be exercised in patients with bladder neck or pyloro-duodenal obstruction.
The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye’s Syndrome.
Promethazine may mask the warning signs of ototoxicity caused by ototoxic drugs e.g. salicylates. It may also delay the early diagnosis of intestinal obstruction or raised intracranial pressure through the suppression of vomiting.
Intravenous injection should be performed with extreme care to avoid extravasation or inadvertent intra-arterial injection, which could lead to necrosis and peripheral gangrene. If a patient complains of pain during intravenous injection, stop the injection immediately, as this may be a sign of extravasation or inadvertent intra-arterial injection. Intramuscular injection must also be performed carefully to avoid inadvertent subcutaneous injection, which could lead to local necrosis.
Promethazine hydrochloride contains Sodium Sulphite and may rarely cause severe hypersensitivity reactions and bronchospasm.
4.5 Interaction with other medicinal products and other forms of interaction
Promethazine hydrochloride will enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic. Alcohol should be avoided during treatment. Promethazine hydrochloride may cause hypotension, and dosage adjustment of antihypertensive therapy may therefore be required. Promethazine hydrochloride may lower the convulsive threshold, and dosage adjustment of anticonvulsant medication may therefore be required. Promethazine hydrochloride may interfere with immunological urine pregnancy tests to produce false-positive or false-negative results. Promethazine hydrochloride should be discontinued at least 72 hours before the start of skin tests as it may inhibit the cutaneous histamine response thus producing false-negative results. Promethazine hydrochloride injection may increase glucose tolerance.
4.6 Fertility, pregnancy and lactation
Promethazine hydrochloride Injection should not be used in pregnancy unless the physician considers it essential. The use of Promethazine hydrochloride is not recommended in the 2 weeks prior to delivery in view of the risk of irritability and excitement in the neonate.
Available evidence suggests that the amount excreted in milk is insignificant. However, there are risks of neonatal irritability and excitement.
4.7 Effects on ability to drive and use machines
Ambulant patients receiving Promethazine hydrochloride for the first time should not be in control of vehicles or machinery for the first few days until it is established that they are not hypersensitive to the central nervous effects of the drug and do not suffer from disorientation, confusion or dizziness.
4.8 Undesirable effects
The following CIOMS frequency rating is used: 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), not known (cannot be estimated from the available data).
Side effects may be seen in a few patients: drowsiness, dizziness, restlessness, headaches, nightmares, tiredness, and disorientation. Anticholinergic side effects such as blurred vision, dry mouth and urinary retention occur occasionally. Newborn and premature infants are susceptible to the anticholinergic effects of promethazine, while other children may display paradoxical hyperexcitability. The elderly are particularly susceptible to the anticholinergic effects and confusion due to promethazine. Other side-effects include anorexia, gastric irritation, palpitations, hypotension, arrhythmias, extrapyramidal effects, muscle spasms and tic-like movements of the head and face. Jaundice and blood dyscrasias including haemolytic anaemia rarely occur. Very rare cases of allergic reactions, including urticaria, rash, pruritus and anaphylaxis, have been reported.
Photosensitive skin reactions have been reported; strong sunlight should be avoided during treatment.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
4.9 Overdose
Symptoms of severe overdosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children: coma or excitement may precede their occurrence. Cardiorespiratory depression is uncommon. If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the antiemetic effect of promethazine; alternatively, gastric lavage may be used.
Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable anticonvulsant.
- Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antihistamines for systemic use; Phenothiazine derivatives.
Potent, long acting, antihistamine with additional anti-emetic central sedative and anti-cholinergic properties
5.2 Pharmacokinetic properties
Promethazine is slowly excreted via urine and bile. It is distributed widely in the body. It enters the brain and crosses the placenta. Phenothiazines pass into the milk at low concentrations.
5.3 Preclinical safety data
No additional data of relevance to the prescriber.
- Pharmaceutical particulars
6.1 List of excipients
Sodium sulphite anhydrous
Sodium metabisulphite
Water for injections
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
Store in the original carton in order to protect from light.
6.5 Nature and contents of container
Cardboard carton containing either 10 x 1 ml ampoules or 10 x 2 ml ampoules.
Not all pack sizes may be marketed
6.6 Special precautions for disposal and other handling
Discoloured solutions should not be used.
- Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com
Promethazine hydrochloride Injection 25mg/ml, 50mg/ml
PACKAGE LEAFLET: INFORMATION FOR THE USER
Promethazine hydrochloride 25mg/ml, Solution for Injection Taj Pharma
Promethazine hydrochloride
Read all of this leaflet carefully before you are given this medicine because it contains important information for you
- Keep this leaflet. You may need to read it again
- If you have any further questions, ask your doctor or pharmacist
- If you get any side-effects, talk to your doctor, pharmacist or nurse. (see section 4).
What is in this leaflet:
- What Promethazine hydrochloride Injection is and what it is used for
2. What you need to know before you are given Promethazine hydrochloride Injection
3. How Promethazine hydrochloride Injection will be given
4. Possible side effects
5. How to use Promethazine hydrochloride Injection
6. Contents of the pack and other Information - What Promethazine hydrochloride Injection is and what it is used for
Promethazine hydrochloride Injection contains a medicine called promethazine hydrochloride. This belongs to a group of medicines called phenothiazines. It works by blocking a natural substance (histamine) that your body makes during an allergic reaction. It also works directly on the brain to help you feel more relaxed.
What Promethazine hydrochloride Injection is used for
- To treat allergic conditions such as hay fever or rashes (like nettle rash or hives)
- As a sedative for both adults and children. This is a medicine given to reduce awareness or make you feel relaxed and at ease
- To treat adults with difficulty sleeping (insomnia)
- To help you feel more relaxed before an operation
- What you need to know before you are given Promethazine hydrochloride Injection
Do not use this medicine if:
- The person taking the medicine is under 2 years of age
- You are allergic (hypersensitive) to promethazine hydrochloride or any of the other ingredients of Promethazine hydrochloride Injection (listed in Section 6 below). The signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
- You are taking a medicine for depression called a monoamine oxidase inhibitor (MAOI). Also do not take Promethazine hydrochloride Injection if you have stopped taking one of these MAOI medicines within the last 14 days. If you are not sure ask your doctor or pharmacist (see “Other medicines and Promethazine hydrochloride Injection” section below)
- The person is unconscious (in a coma) or suffers from severe dizziness, drowsiness or headache
You should not be given this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before having Promethazine hydrochloride Injection.
Warnings and precautions
Do not have this medicine and tell your doctor if:
- You have difficulty breathing, wheezing, tightness in the chest (asthma) or an infection in your lungs (bronchitis)
- You have epilepsy
- You have any serious heart problems
- You have liver or kidney problems
- You have a stomach blockage or difficulty passing water
- You have a headache due to dehydration or high blood pressure
- You have increased pressure in the eye (narrow angle glaucoma)
- You have had something called Reye’s Syndrome or possible Reye’s Syndrome – signs include being sick and confused following a viral illness
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before having Promethazine hydrochloride Injection.
Other medicines and Promethazine hydrochloride Injection
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you can buy without prescription, including herbal medicines. This is because Promethazine hydrochloride Injection can affect the way some medicines work. Also some medicines can affect the way Promethazine hydrochloride Injection works.
Do not take this medicine, and tell your doctor, if you are taking or have taken the following in the last 2 weeks:
- Some medicines for depression called monoamine oxidase inhibitors (MAOIs). If you are not sure ask your doctor or pharmacist
Tell your doctor or pharmacist if you are taking any of the following:
- Anticholinergic medicines – includes some medicines used for irritable bowel syndrome, asthma or weak bladder. These can increase the risk of dizziness, dry mouth and blurred eyesight
- Medicines for depression (such as amitriptyline)
- Medicines to help you to sleep or feel more relaxed (such as diazepam or zolpidem)
- Medicines such as aspirin (for arthritis and pain in your joints). Promethazine hydrochloride Injection may hide the side effects of these medicines
- Medicines for high blood pressure
- Medicines for fits (epilepsy)
- Medicines for diabetes. Your doctor may need to change the dose of your medicine
Promethazine hydrochloride Injection with food and drink
Do not drink alcohol while you are having Promethazine hydrochloride Injection. This is because it can affect the way the medicine works.
Pregnancy and breast-feeding
Talk to your doctor before having this medicine if you are pregnant, might become pregnant, or think you may be pregnant. You should not have Promethazine hydrochloride Injection 2 weeks before you give birth.
You should not have Promethazine hydrochloride Injection if you are breast-feeding. This is because small amounts may pass into mothers’ milk. This can be harmful to your baby.
If you are breast-feeding or planning to breastfeed, talk to your doctor or pharmacist before taking any medicine.
Driving and using machines
You may feel drowsy, dizzy or confused while having this medicine or in the morning after taking this medicine. If this happens, do not drive or use any tools or machines.
Promethazine hydrochloride Injection contains:
- Sodium sulphite and sodium metabisulphite. These may rarely cause severe allergic (hypersensitivity) reactions and difficulty breathing, wheezing and tightness in the chest (bronchospasm)
- Sodium. It contains 0.4mg sodium per ml and is essentially ‘sodium-free’.
- How Promethazine hydrochloride Injection will be given
Your medicine will normally be given to you by a doctor or nurse. This is because it needs to be given by a deep injection into a muscle or by a slow injection into the vein.
Having this medicine
- This medicine is usually given by a deep injection into a muscle. It can also be given by a slow injection into the vein after dilution using water for injection
- If you feel the effect of your medicine is too weak or too strong, tell your doctor
How much is given
The usual dose is:
Children 5-10 years:
- 6.25 to12.5mg given by deep injection into a muscle
Children over 10 years and adults (including the elderly):
- 25 to 50mg given by deep injection into a muscle. It can also be given in an emergency by a slow injection into a vein after being mixed with water for injections.
The maximum dose is 100mg.
If you are not sure why you are being given Promethazine hydrochloride Injection or have any questions about how much Promethazine hydrochloride Injection is being given to you, speak to your doctor or nurse.
Exposure to sunlight
Promethazine hydrochloride Injection can make your skin more sensitive to sunlight.
Keep out of direct sunlight while taking this medicine.
If you have more Phernergan Injection than you should
It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will be monitoring your progress, and checking the medicine that you are given. Always ask if you are not sure why you are getting a dose of medicine.
The following effects may happen:
In children: Excitation, moving unsteadily or stumbling, uncontrolled writhing movements especially of the hands or feet, hallucinations, fits (seizures), loss of consciousness, uneven heart beat and breathing difficulties.
In adults: Feeling sleepy or drowsy, fits, loss of consciousness, uneven heart beat and breathing difficulties.
If you miss a dose of Promethazine hydrochloride Injection
Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However if you do think you have missed a dose, tell your doctor or nurse.
If you have any further questions on the use of this product, ask your doctor or nurse.
Tests
Having Promethazine hydrochloride Injection may affect the results of certain tests. These include some pregnancy tests and skin tests. Promethazine hydrochloride Injection should not be given at least 3 days before the start of a skin test.
- Possible side effects
Like all medicines, Promethazine hydrochloride Injection can cause side effects, although not everybody gets them.
Tell a doctor or nurse straight away if you have:
- An allergic reaction. The signs may include: a rash, hives, itchiness swallowing or breathing problems, swelling of your lips, face, throat or tongue
- Liver problems that may cause the eyes or skin to go yellow (jaundice)
- Muscle stiffness or shaking
- Being unable to control some muscles in your head or face
- You notice unusual movements of the tongue, facial muscle spasms, rolling eyes and trembling
- Very fast, uneven or forceful heartbeat (palpitations)
- Tiredness which lasts for a long time. This may be due to a blood problem called anaemia
- Over-active behaviour in children
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet.
- Dry mouth, blurred eyesight or you can not pass water (urine)
- Feeling drowsy or sleepy, tiredness, disorientation, having nightmares, headaches, feeling restless
- If you have a headache this may be as a result of high blood pressure and/or dehydration and you are advised to see your doctor.
- Loss of appetite (anorexia), sore stomach
- Feeling dizzy, lightheaded, faint (hypotension)
- Feeling confused, especially in elderly people
- Being more sensitive to the sun than usual. If this happens keep out of direct sunlight and do not use sun lamps
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
By reporting side effects you can help provide more information on the safety of this medicine.
- How to store Promethazine hydrochloride Injection
- This medicine will be kept by your doctor or pharmacist in a safe place where children cannot see or reach it
- Do not have Promethazine hydrochloride Injection after the expiry date which is stated on the carton and ampoule after EXP. The expiry date refers to the last day of that month
- Store in the original carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
- Contents of the pack and other Information
What Promethazine hydrochloride Injection contains
- Each 1ml ampoule contains 25mg, 50mg of the active substance, promethazine hydrochloride
- The other ingredients are sodium sulphite anhydrous, sodium metabisulphite and water for injection
What Promethazine hydrochloride Injection looks like and contents of the pack
Promethazine hydrochloride Injection is a colourless or almost colourless solution. Your solution for injection is available in cartons containing 10 x 1ml ampoules or 10 x 2ml ampoules.
Not all pack sizes may be marketed.
- Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com
