1. NAME OF THE MEDICINAL PRODUCT

Phenylephrine Hydrochloride Injection USP 10mg/1ml Taj Pharma
Phenylephrine Hydrochloride Injection USP 50mg/5ml Taj Pharma
Phenylephrine Hydrochloride Injection USP 100mg/10ml Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

a) Phenylephrine Hydrochloride Injection USP 10mg/1ml
Each ml contains:
Phenylephrine Hydrochloride USP   10mg
Sodium Chloride                               3.5mg
Trisodium Citrate dehydrate                4mg
Citric acid                                          1mg
Water for Injection                             q.s

b) Phenylephrine Hydrochloride Injection USP 50mg/5ml
Each ml contains:
Phenylephrine Hydrochloride USP   10mg
Sodium Chloride                               3.5mg
Trisodium Citrate dehydrate                4mg
Citric acid                                          1mg
Water for Injection                              q.s

c) Phenylephrine Hydrochloride Injection USP 100mg/10ml
Each ml contains:
Phenylephrine Hydrochloride USP    10mg
Sodium Chloride                                3.5mg
Trisodium Citrate dehydrate                4mg
Citric acid                                          1mg
Water for Injection                              q.s

 

For a full list of excipients, see section 6.1

  1. PHARMACEUTICAL FORM

Solution for injection, or concentrate for solution for injection or infusion.

Clear, colourless, sterile, solution.

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

For the treatment of hypotensive states, e.g. circulatory failure, during spinal anaesthesia or drug-induced hypotension.

4.2 Posology and method of administration

For subcutaneous, intramuscular or slow intravenous injection or by intravenous infusion.

Whenever solution and container permit, parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.

Adults

Phenylephrine injection may be administered subcutaneously or intramuscularly in a dosage of 2 to 5 mg with further doses of 1 to 10 mg if necessary according to response, or in a dose of 100 to 500 micrograms by slow intravenous injection as a 0.1% solution, repeated as necessary after at least 15 minutes.

Alternatively, 10 mg in 500 ml of glucose 5% injection or sodium chloride 0.9% injection may be infused intravenously, initially at a rate of up to 180 micrograms per minute, reduced according to response to 30-60 micrograms per minute.

Children

100 micrograms/kg bodyweight subcutaneously or intramuscularly.

Elderly

There is no need for dosage reduction in the elderly.

4.3 Contraindications

Hypersensitivity to phenylephrine or to any of the excipients listed in section 6.1.

Patients taking monoamine oxidase inhibitors, or within 14 days of ceasing such treatment.

Severe hypertension and hyperthyroidism.

Avoid in patients with prostatic enlargement.

4.4 Special warnings and precautions for use

Great care should be exercised in administering Phenylephrine Injection to patients with pre-existing cardiovascular disease such as ischaemic heart disease, arrhythmias, occlusive vascular disease including arteriosclerosis, hypertension or aneurysms. Anginal pain may be precipitated in patients with angina pectoris.

Care is also required when given to patients with diabetes mellitus or closed-angle glaucoma.

Keep all medicines out of the reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

Phenylephrine may interact with cyclopropane and halothane and other halogenated inhalational anaesthetics, to induce ventricular fibrillation.

An increased risk of arrhythmias may also occur if phenylephrine injection is given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.

Phenylephrine may increase blood pressure and consequently reverse the action of many antihypertensive agents.

Interactions of phenylephrine with alpha and beta receptor blocking drugs may be complex. Drugs which have an effect on α1– adrenoreceptors could potentiate (such as ganisetron or clonidine) or inhibit (such as doxazosin or buspirone) the vasopressive action of phenylephrine.

Caution should be applied when administering atomoxetine concurrently, as there is potential for synergistic pharmacological effects.

Severe hypertension may occur following the use of phenylephrine and atropine or other antimuscarinics.

The pressor effects of phenylephrine may be slightly reduced by lithium carbonate.

The effects of phenylephrine may be potentiated by the use of monoamine oxidase inhibitors or reversible inhibitors of monoamine oxidase.

4.6 Pregnancy and lactation

The safety of phenylephrine during pregnancy and lactation has not been established. Due to the vasoconstrictive properties of phenylephrine, the product should be used with caution in patients with a history of pre-eclampsia. Administration of phenylephrine in late pregnancy or labour may cause foetal hypoxia and bradycardia.

Excretion of phenylephrine in breast milk appears to be minimal.

4.7 Effects on ability to drive and use machines

No adverse effects known.

4.8 Undesirable effects

Immune system disorders

Hypersensitivity

Metabolism and nutrition disorders

Metabolic disorders

Psychiatric disorders

Nervousness, insomnia

Nervous system disorders

Headache, cerebral haemorrhage, paraesthesia

Eye disorders

Mydriasis, angle-closure glaucoma

Cardiac disorders

Pulmonary oedema, bradycardia, tachycardia, arrhythmia, angina pectoris, palpitations, cardiac arrest

Vascular disorders

Hypotension, dizziness, syncope, flushing

Respiratory, thoracic and mediastinal disorders

Dyspnoea

Gastrointestinal disorders

Vomiting, salivary hypersecretion

Renal and urinary disorders

Dysuria, urinary retention

General disorders and administration site conditions

Extravasation, infusion site necrosis, hyperhidrosis

Investigations

Increased blood pressure, abnormal blood glucose

Phenylephrine is without significant stimulating effects on the central nervous system at usual doses.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4.9 Overdose

Symptoms of overdosage include headache, vomiting, hypertension and reflex bradycardia and other cardiac arrhythmias. In severe cases confusion, hallucinations and seizures may occur.

Treatment should consist of symptomatic and supportive measures. The hypertensive effects may be treated with an alpha-adrenoceptor blocking drug, such as phentolamine, 5 to 60 mg i.v. over 10-30 minutes, repeated as necessary.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Adrenergic and dopaminergic agents.

Phenylephrine hydrochloride is a sympathomimetic agent with mainly direct effects on adrenergic receptors. It has predominantly alpha-adrenergic activity and is without significant stimulating effects on the central nervous system at usual doses. After injection it produces peripheral vasoconstriction and increased arterial pressure. It also causes reflex bradycardia.

5.2 Pharmacokinetic properties

When injected subcutaneously or intramuscularly, phenylephrine takes 10 to 15 minutes to act. Subcutaneous and intramuscular injections are effective for up to about one and up to two hours respectively. Intravenous injections are effective for up to about 20 minutes. Phenylephrine is metabolised in the liver by monoamine oxidase. The metabolites, their route and rate of excretion have not been identified.

5.3 Preclinical safety data

Phenylephrine has been used to induce cardiac myocyte hypertrophy in cultures of rat neonatal mycocytes at doses of 100 µM and 10 µM. To the best of our knowledge there have been no human studies associating therapeutic phenylephrine use with the development of cardiac myocyte hypertrophy.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium Hydroxide

Hydrochloric Acid

Water for Injections

6.2 Incompatibilities

Phenylephrine Injection has been stated to be incompatible with alkalis, ferric salts, phenytoin sodium and oxidising agents.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

Keep out of sight and reach of children.

Store below 25°C. Store in the original package.

6.5 Nature and contents of container

1 ml neutral glass ampoule with ceramic breakring.

Pack size: 10 ampoules

6.6 Special precautions for disposal and other handling

Not applicable.

 

7.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

Phenylephrine Hydrochloride Injection USP 10mg/1ml Taj Pharma
Phenylephrine Hydrochloride Injection USP 50mg/5ml Taj Pharma
Phenylephrine Hydrochloride Injection USP 100mg/10ml Taj Pharma

Package Leaflet: Information for the User

PHENYLEPHRINE 10MG/ML SOLUTION FOR INJECTION OR INFUSION

(Referred to as Phenylephrine Injection in this leaflet)

Read all of this leaflet carefully before you are given this medicine.

  • Keep this leaflet. You may need to read it

again.

  • If you have any further questions, ask your doctor or nurse.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

In this leaflet:

1.What Phenylephrine Injection is and what it is used for
2.Before you are given Phenylephrine Injection
3.How Phenylephrine Injection will be given
4.Possible side effects
5.How to store Phenylephrine Injection
6.Further information

  1. WHAT PHENYLEPHRINE INJECTION IS AND WHAT IT IS USED FOR

Phenylephrine Injection contains phenylephrine hydrochloride, which belongs to a group of medicines known as adrenergic cardiac stimulants. It raises blood pressure by constricting blood vessels.

Phenylephrine Injection is used to treat low blood pressure, which may be caused by circulatory failure, spinal anaesthesia or certain medicines.

  1. BEFORE YOU ARE GIVEN PHENYLEPHRINE INJECTION

You should NOT be given Phenylephrine Injection if any of the following apply to you. Tell your doctor if:

  • you are allergic (hypersensitive) to phenylephrine hydrochloride or any of the other ingredients (listed in section 6)
  • you suffer from high blood pressure
  • you have an overactive thyroid
  • you are taking Monoamine Oxidase Inhibitors (MAOIs) used to treat depression, or have taken them in the last 14 days.
  • you suffer from prostatic enlargement

 

Special care should be taken with Phenylephrine Injection if any of the following apply to you.

Tell your doctor if you have:

  • any heart problems or disease, including arrhythmias or angina
  • a disease of your blood vessels, such as arteriosclerosis or aneurysms
  • diabetes mellitus
  • closed-angle glaucoma (increased pressure in the eye)
  • you are pregnant or breast-feeding.

Taking other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular, tell your doctor or nurse if you are taking any of the following:

  • anaesthetics given as a gas that you inhale, such as cyclopropane or halothane
  • tricyclic antidepressants
  • medicines used to treat heart conditions including cardiac glycosides or quinidine
  • medicines used to treat high blood pressure
  • medicines known as alpha blockers (used to treat Reynaud’s syndrome or tumour of the adrenal gland) or beta blockers (used to treat heart conditions or reduce blood pressure).
  • ganisetron used to prevent nausea and vomiting
  • clonidine used to treat high blood pressure.
  • doxazosin used to treat high blood pressure or symptoms of an enlarged prostate
  • buspirone used to treat anxiety.
  • atomoxetine used to treat attention-deficit hyperactivity disorder (ADHD)
  • lithium carbonate a drug used for depression or aggression.
  • monoamine oxidase inhibitors medications prescribed for the treatment of depression.
  • atropine or other antimuscarinics used to treat certain types of nerve agent

Pregnancy and breast-feeding

Tell your doctor or nurse if you are pregnant or breast-feeding.

The safety of phenylephrine during pregnancy and breast-feeding has not been established. Giving phenylephrine in late pregnancy or labour may reduce the foetal heart rate and oxygen levels.

  1. HOW PHENYLEPHRINE INJECTION WILL BE GIVEN

You will normally be given Phenylephrine Injection in a hospital or clinic.

Phenylephrine Injection can be given by an injection under the skin, into a muscle, or diluted and given by slow injection or infusion (drip) into a vein.

Dose for adults, including the elderly: When given under the skin or into a muscle the usual dose is 2 to 5 mg with further doses of 1 to 10 mg if necessary.

When given as a diluted solution by slow injection into a vein the dose is 100 to 500 micrograms, repeated as necessary after at least 15 minutes.

Alternatively, it may be infused as a diluted solution into a vein (drip), and the dose adjusted according to the response.

Dose for children:

The usual dose is 100 micrograms/kg bodyweight given as an injection under the skin or into a muscle.

If you are given more Phenylephrine Injection than you should

As you will be given Phenylephrine Injection in a hospital or clinic by a qualified healthcare professional, this will be unlikely.

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

  1. POSSIBLE SIDE EFFECTS

Like all medicines, Phenylephrine Injection can cause side effects, although not everybody gets them.

Tell your doctor or nurse if you have any of the following side effects:
  • allergic reaction
  • a change in your heart rate (speeding up, slowing down or cessation, palpitations)
  • an irregular heart beat (arrhythmias)
  • chest pain or pain due to angina
  • an increase in blood pressure with headache and vomiting, which may cause bleeding in the brain or fluid in the lungs
  • a decrease in blood pressure with dizziness
  • difficulty in passing urine or urine retention
  • fainting or flushing
  • difficulty breathing
  • nervousness
  • excessive dilation of the pupil
  • difficulty sleeping
  • tissue damage at the site of the
  • angle-closure glaucoma (when pressure rises quickly inside the eyes)
Other side effects
  • sweating
  • excessive production of saliva
  • a feeling of fullness in the head
  • tingling or coolness of the skin
  • altered metabolism including glucose metabolism.
Reporting of side effects

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.

  1. HOW TO STORE PHENYLEPHRINE INJECTION

Keep out of the sight and reach of children. Store below 25ºC. Store in the original package.

Do not use after the expiry date, which is stated on the carton and ampoule.

  1. FURTHER INFORMATION

What Phenylephrine Injection contains

  • Each 1ml ampoule contains 10mg of the active substance phenylephrine hydrochloride
  • The other ingredients are sodium hydroxide, hydrochloric acid and water for
What Phenylephrine Injection looks like and contents of the pack

Phenylephrine Injection is a clear, colourless, sterile solution in a glass ampoule, available in packs of 10 ampoules.

7.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