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Morphine Sulfate Injection USP 4mg

  1. Name of the medicinal product

Morphine Sulfate 4mg Injection Taj Pharma
Morphine Sulfate 8mg Injection Taj Pharma
Morphine Sulfate 10mg Injection Taj Pharma

  1. Qualitative and quantitative composition

Each 1mL contains 4mg of Morphine Sulfate USP
Each 1mL contains 8mg of Morphine Sulfate USP
Each 1mL contains 10mg of Morphine Sulfate USP

  1. Pharmaceutical form

Solution for injection.

  1. Clinical particulars

4.1 Therapeutic indications

Morphine Sulfate Solution for Injection is indicated for the relief of moderate to severe pain. Morphine is used especially in pain associated with cancer, myocardial infarction and surgery. Morphine also helps to relieve the anxiety and insomnia which may be associated with severe pain.

4.2 Posology and method of administration

Adults and children over 12 years:

Morphine Sulfate Solution for Injection is formulated for use by the intravenous route in Patient Controlled Analgesia (PCA) systems. PCA, which permits adjustment of dosage according to the patient’s individual needs, must only be carried out in departments and by staff who are trained and have experience of the system. Patient selection for the use of PCA must ensure that the patient is capable of understanding and following the instructions of the medical/nursing staff. The specific department or unit protocols must be covered to ensure aseptic transfer of the contents of the vial to the PCA system.

There is a considerable variation in analgesic requirements among patients and therefore individualised treatment strategies are required. Dosage should be based on the severity of the pain and the response and opiate tolerance of the patient.

Loading Dose

Loading doses of typically between 1mg and 10mg (maximum 15mg) of morphine sulfate may be given by intravenous infusion over four or five minutes. The loading dose used will depend upon the patient’s diagnosis and conditions.

PCA demand dose

An initial demand dose of 1mg Morphine Sulfate Solution for Injection with a lockout period of 5 to 10 minutes is recommended. Dosages may vary depending on the loading dose, the tolerance and condition of the patient, and whether a background infusion of morphine sulfate is being given.

The patient should be specifically monitored for pain, sedation and respiratory rate during the first few hours of treatment to ensure that the dosage regimen is suitable.

The duration of treatment should be kept to a minimum, although dependence and tolerance are not generally a problem when morphine is used legitimately in patients with opioid-sensitive pain.

Use in children:

Not recommended for children under 12 years.

Use in the elderly:

Morphine doses need to be reduced in elderly patients.

Discontinuation of therapy

An abstinence syndrome may be precipitated if opioid administration is suddenly discontinued. Therefore the dose should be gradually reduced prior to discontinuation.

4.3 Contraindications

Morphine Sulfate Solution for Injection should not be given to patients with known hypersensitivity to morphine or other opioid preparations. Use of Morphine Sulfate Solution for Injection is also contraindicated in patients with respiratory depression; obstructive airways disease; excessive bronchial secretions; during a bronchial asthma attack or in heart failure secondary to chronic lung disease; head injury; raised intra-cranial pressure; coma; convulsion disorders; ulcerative colitis; in presence of a risk of paralytic ileus; biliary and renal tract spasm and acute alcoholism; phaeochromocytoma.

Morphine Sulfate Solution for Injection should not be given to patients with moderate to severe renal impairment (glomerular filtration rate <20mL/min) or with severe or acute liver failure.

Morphine Sulfate Solution for Injection is contraindicated in patients receiving monoamine oxidase inhibitors or within two weeks of discontinuing such treatment. Use of Morphine Sulfate Solution for Injection during pregnancy or lactation is not recommended.

4.4 Special warnings and precautions for use

As with other narcotics, a dose reduction may be appropriate in elderly patients, in patients with hypothyroidism, renal and chronic hepatic disease.

Morphine Sulfate Solution for Injection should be used with caution in debilitated patients and those with Acute chest syndrome (ACS) in patients with sickle cell disease (SCD); adrenal insufficiency; hypopituitarism; prostatic hypertrophy; shock; diabetes mellitus; diseases of the biliary tract; myasthenia gravis; cardiac arrhythmias; excessive obesity; hypotension and severe cardiac failure. It should also be used with caution post-operatively following total joint arthroplasty (colonic pseudo-obstruction).

Acute chest syndrome (ACS) in patients with sickle cell disease (SCD)

Due to a possible association between ACS and morphine use in SCD patients treated with morphine during a vaso-occlusive crisis, close monitoring for ACS symptoms is warranted.

Adrenal insufficiency

Opioid analgesics may cause reversible adrenal insufficiency requiring monitoring and glucocorticoid replacement therapy. Symptoms of adrenal insufficiency may include e.g. nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, or low blood pressure.

Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of Morphine Sulfate 2mg in 1mL Solution for Injection and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Morphine Sulfate 2mg in 1mL Solution for Injection concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).

Hyperalgesia that does not respond to a further dose increase of morphine may occur in particular in high doses. A morphine dose reduction or change in opioid may be required.

Plasma concentrations of morphine may be reduced by rifampicin. The analgesic effect of morphine should be monitored and doses of morphine adjusted during and after treatment with rifampicin.

Morphine has an abuse potential similar to other strong agonist opioids, and should be used with particular caution in patients with a history of alcohol or drug abuse.

Dependence and withdrawal (abstinence) syndrome

Use of opioid analgesics may be associated with the development of physical and/or psychological dependence or tolerance. The risk increases with the time the drug is used, and with higher doses. Symptoms can be minimised with adjustments of dose or dosage form, and gradual withdrawal of morphine. For individual symptoms, see section 4.8.

Decreased Sex Hormones and increased prolactin

Long-term use of opioid analgesics may be associated with decreased sex hormone levels and increased prolactin. Symptoms include decreased libido, impotence or amenorrhea.

This medicinal product contains 3.6mg sodium per 1mL, equivalent to 0.2 % of the WHO recommended maximum daily intake of 2g sodium for an adult.

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant or recent use of monoamine oxidase inhibitors with morphine is contraindicated since interactions have been reported, resulting in CNS excitation or depression with hyper or hypotensive crises.

The CNS depressant effects of morphine are increased by the co-administration of CNS depressants including alcohol, anaesthetics, muscle relaxants, hypnotics, sedatives, tricyclics, neuroleptics and phenothiazines. Hyperpyrexia and CNS toxicity may result from an opiate selegiline combination. Sedative medicines such as benzodiazepines or related drugs: The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose and duration of concomitant use should be limited (see section 4.4)

The analgesic effects of opioids tend to be enhanced by the concomitant administration of dexamfetamine, hydroxyzine and some phenothiazines (although the latter may also cause respiratory depression). Morphine may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. The combination of morphine with anticholinergics may enhance the constipatory effect and urinary retention.

Cimetidine and ranitidine appear to interfere with the metabolism of morphine and the metabolism and excretion of morphine may be inhibited by disulfiram. Increased morphine levels may result from the co-administration of cisapride. Metoclopramide and domperidone may antagonise morphine’s gastrointestinal effects and metoclopramide enhances its sedative effect. Ciprofloxacin concentration may be reduced and mexiletine absorption delayed by co-administered opiate. Animal data suggest that propranolol may increase the toxicity of opioids. Ritonavir can induce the formation of metabolising enzymes made in the liver and can cause increased metabolism of morphine sulfate which can reduce the clinical efficacy of the analgesic.

Both antipsychotics and morphine sulfate have sedative effects which can be addictive when co-administered.

Co-administration of morphine sulfate with esmolol results in a slight increase in the esmolol levels, but the clinical implications of this increase are not considered very significant.

4.6 Fertility, pregnancy and lactation

Fertility

Animal studies have shown that morphine may reduce fertility (see 5.3. preclinical safety data).

Pregnancy

Newborns whose mothers received opioid analgesics during pregnancy should be monitored for signs of neonatal withdrawal (abstinence) syndrome. Treatment may include an opioid and supportive care.

Breast-feeding

Morphine has been shown to suppress lactation, although morphine is secreted in breast milk and may cause respiratory depression in the infant.

4.7 Effects on ability to drive and use machines

Morphine may modify the patient’s reactions to a varying extent depending on the dosage and individual susceptibility. Ambulatory patients should be warned not to use machines.

This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

  • The medicine is likely to affect your ability to drive
  • Do not drive until you know how the medicine affects you
  • It is an offence to drive while under the influence of this medicine

However, you would not be committing an offence (called ‘statutory defence’) if:

o The medicine has been prescribed to treat a medical or dental problem and

o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and

o It was not affecting your ability to drive safely.

4.8 Undesirable effects

The side-effects most commonly seen with morphine and other opioids are respiratory depression, nausea, vomiting, constipation, drowsiness and confusion. With long term use these symptoms generally lessen, although constipation frequently persists.

The following adverse effects are from published literature and frequencies are not known.

Psychiatric disorders

Restlessness, mood changes, hallucinations, delirium, disorientation, excitation, agitation, sleep disturbance dependence.

Nervous system disorders

Headache, vertigo, euphoria, dsyphoria, dizziness, taste disturbances, seizures, paraesthesia, raised intracranial pressure hyperhidrosis, allodynia and hyperalgesia (see section 4.4).

Endocrine

Long term use of opioid analgesics can cause adrenal insufficiency. Exacerbation of pancreatitis.

Eye disorders

Visual disturbances, nystagmus, miosis.

Ear and Labyrinth disorders

Vertigo.

Cardiac disorders

Bradycardia, tachycardia, palpitations, hypotension, hypertension, syncope.

Vascular disorders

Orthostatic hypotension, facial flushing, oedema.

Gastrointestinal disorders

Dry mouth, dyspepsia, paralytic ileus, abdominal pain, anorexia.

Hepatobiliary disorders

Biliary spasm.

Immune system disorders

Anaphylactioid reactions. Anaphylactic reactions to morphine have been reported rarely.

Musculoskeletal, connective tissue and bone disorder

Muscle fasciculation, myoclonus, rhabdomyolysis, muscle rigidity.

Renal and urinary disorders

Difficult micturition, ureteric spasm, urinary retention.

Reproduction and sexual disorders

Long term use of opioid analgesics can cause hypogonadism in both men and women. This can lead to amenorrhoea, reduced libido, infertility, depression and erectile dysfunction.

Respiratory disorders

Bronchospasm (in association with anaphylaxis), inhibition of cough reflex.

Skin and subcutaneous tissue disorders

Rashes, urticaria, pruritus.

General disorders and administration site conditions.

Sweating, hypothermia, malaise, asthenia, pain and irritation at the injection site, drug withdrawal (abstinence) syndrome.

Long Term Use

Tolerance and psychological and physical dependence may occur. Decreased potency may be experienced. High doses may produce respiratory depression and hypotension, with deepening coma. Convulsions may occur particularly in infants.

Drug Withdrawal

Dysphoric mood and anxiety

Drug dependence and withdrawal (abstinence) syndrome

Use of opioid analgesics may be associated with the development of physical and/or psychological dependence or tolerance. An abstinence syndrome may be precipitated when opioid administration is suddenly discontinued or opioid antagonists administered, or can sometimes be experienced between doses. For management, see 4.4.

Physiological withdrawal symptoms include: Body aches, tremors, restless legs syndrome, diarrhoea, abdominal colic, nausea, flu-like symptoms, tachycardia and mydriasis. Psychological symptoms include dysphoric mood, anxiety and irritability. In drug dependence, “drug craving” is often involved.

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

Signs:

The signs of morphine overdose consist of pin-point pupils, respiratory depression, Pneumonia aspiration and hypotension. Death may occur from respiratory failure. Circulatory failure and deepening coma may develop in severe cases and death may ensue. Less severe cases may be manifest by nausea, vomiting, tremor, dysphoria, hypothermia, hypotension, confusion and sedation. Rhabdomyolysis progressing to renal failure can also be a consequence of overdosage.

Treatment:

It is vital to maintain and support respiration and circulation. The specific opioid antagonist naloxone should be employed for the reversal of coma and restoration of spontaneous respiration. 400 micrograms of naloxone should be administered intravenously, repeated at 2-3 minute intervals as necessary up to a maximum dose of 10mg.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Natural opium alkaloids.

Morphine acts as a competitive agonist at opiate receptors in the CNS, particularly mu and to a lesser extent kappa receptors. Activity at the mu- 1 subtype receptor is thought to mediate analgesia, euphoria and dependence whilst activity at the mu-2 receptor is thought to be responsible for respiratory depression and inhibition of gut motility. Action at the kappa receptor may mediate spinal analgesia. The analgesic action of morphine is effective at several spinal and supraspinal sites.

5.2 Pharmacokinetic properties

Onset of action is rapid following parenteral administration of morphine with peak analgesic effect occurring within 20 minutes via the intravenous route.

Morphine is widely distributed in the body, with an apparent volume of distribution of 2 – 3Lkg-1. Due to its relatively hydrophilic nature, morphine does not readily cross the blood-brain barrier although it is detectable in the cerebrospinal fluid.

Morphine is extensively metabolised by the liver. Renal glucuronidation also takes place. The major metabolite, quantitatively, is morphine-3-glucronide although morphine-6-glucuronide is significant in terms of potency.

The metabolites are excreted mainly via the renal route.

5.3 Preclinical safety data

The toxicological profile of morphine in animals has not been systematically identified as a result of its established widespread clinical use. Recent animal studies have confirmed some targets for morphine toxicity. A nephrotoxic action has been reported in rats following subcutaneous administration of relatively high levels (up to 96mg/kg) of morphine. In male rats, reduced fertility and chromosomal damage in gametes have been reported. Adverse effects of morphine on development of the foetus and newborn have been confirmed in rats and mice. Morphine has been shown to reduce the release of LH from the pituitary causing reductions in serum testosterone levels, reduction in the weight of secondary sex organs and reductions in spermatogenic cell populations. The adverse effects of morphine sulfate in both males and females are consistent with recent findings that morphine exhibits significant genotoxic actions in several in vivo test systems. Immunotoxicity associated with morphine treatment has been reported in animal tests for several parameters which provide possible mechanisms for decreased resistance to a range of infections. Evidence suggests that part of this effect may be mediated via release of endogenous corticosterone.

  1. Pharmaceutical particulars

6.1 List of excipients

Sodium Chloride

Water for Injections

6.2 Incompatibilities

Morphine Sulfate Solution for Injection should not be mixed with other preparations.

Morphine salts are incompatible with aminophylline, sodium salts of barbiturates and phenytoin, aciclovir sodium, furosemide, heparin sodium, pethidine HCl, prochlorperazine edisylate and promethazine HCl.

Physicochemical incompatibility (formation of precipitates) has been demonstrated between solutions of morphine sulfate and 5- fluorouracil.

6.3 Shelf life

As packaged for sale:

2 years.

After first opening the container:

For single use only. Discard any unused solution immediately after initial use.

6.4 Special precautions for storage

Store below 25°C. Keep the container in the outer carton. Store vials in an upright position.

6.5 Nature and contents of container

Type II clear glass vials containing 50mL volume, with bromobutyl rubber stoppers and tamper-evident aluminium caps. This product is packed into cartons containing 1 vial or 10 vials. Both pack sizes may not be available at the same time.

6.6 Special precautions for disposal and other handling

For Single Use Only. Discard any unused solution immediately and safely after initial use.

  1. 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

 

Morphine Sulfate Injection USP 4mg, 8mg, 10mg

 

Package Leaflet: Information for the user

Morphine sulfate 4mg in 1mL Solution for Injection Taj Pharma
Morphine sulfate 8mg in 1mL Solution for Injection Taj Pharma
Morphine sulfate 10mg in 1mL Solution for Injection Taj Pharma

Morphine Sulfate

Read all of this leaflet carefully before you start using 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, nurse or pharmacist.
  • If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

  1. What Morphine Sulfate 2mg in 1mL Solution for Injection is and what it is used for
    2. What you need to know before you use Morphine Sulfate 2mg in 1mL Solution for Injection
    3. How to use Morphine Sulfate 2mg in 1mL Solution for Injection
    4. Possible Side Effects
    5. How to store Morphine Sulfate 2mg in 1mL Solution for Injection
    6. Contents of the pack and other information
  2. What Morphine Sulfate 2mg in 1mL Solution for Injection is and what it is used for

Morphine Sulfate, the active ingredient, belongs to a group of strong painkilling medicines called opioids which must be used only under a doctor’s instruction.

This medicine is a solution for injection that has been prepared in water so that it can be used with specially designed pumps which provide a continuous injection into the body. It is used in the long term relief of moderate to severe pain, such as the pain caused by surgery, heart attacks and cancer. This medicine also helps to reduce the anxiety and sleeplessness which may be caused by the pain.

  1. What you need to know before you use Morphine Sulfate 2mg in 1mL Solution for Injection

Do not use Morphine Sulfate 2mg in 1mL Solution for Injection if you:

  • Are allergic to Morphine Sulfate or any other strong painkilling drugs or any other ingredients in this medicine (listed in section 6)
  • Have a history of alcohol abuse
  • Suffer from malfunctioning of the adrenal gland (phaeochromocytoma)
  • Have suffered a head injury
  • Are at risk of a paralytic ileus (reduced gut motility)
  • Have acute respiratory depression (breathlessness)
  • Have raised pressure inside your skull

Check with your doctor if you are concerned about any of the above.

Warnings and Precautions:

Talk to your doctor, pharmacist or nurse before using Morphine Sulfate 2mg in 1mL Solution for Injection if you:

  • Are pregnant or breast feeding
  • Have taken this medicine in the last two weeks
  • Suffer from asthma, chronic bronchitis or have any other illness which causes breathing difficulties
  • Suffer from kidney or liver problems
  • Suffer from stomach or bowel problems
  • Have difficulty in passing urine due to an enlarged prostate
  • Suffer from bad headaches or feel sick
  • Suffer from epilepsy or other fits
  • Suffer from poor blood supply to the heart or other heart problems
  • Have low blood pressure (hypotension)
  • Have a tumour of the adrenal gland
  • Suffer from myasthenia gravis
  • Suffer from pain from gallstones (biliary colic)
  • Suffer from thyroid problems
  • Are elderly and/or debilitated
  • Increased sensitivity to pain despite the fact that you are taking increasing doses (hyperalgesia).
    Your doctor will decide whether you will need a change in dose or a change in strong analgesic (“painkiller”), (see section 2).
  • Weakness, fatigue, lack of appetite, nausea, vomiting or low blood pressure. This may be a symptom of the adrenals producing too little of the hormone cortisol, and you may need to take hormone supplement.
  • Loss of libido, impotence, cessation of menstruation. This may be because of decreased sex hormone production.
  • If you have once been dependent on drugs or alcohol. Also tell if you feel that you are becoming dependent on Morphine Sulfate 2mg in 1mL Solution for Injection while you are using it. You may have started to think a lot about when you can take the next dose, even if you do not need it for the pain.
  • Abstinence symptoms or dependence. The most common abstinence symptoms are mentioned in section 3. If this occurs, your doctor may change the type of medicine or the times between doses.

Check with your doctor if you are concerned about any of the above. This medicine is only suitable for long lasting pain and is not intended for pain which only lasts for short periods.

NEVER give your medication to other people even if their symptoms are the same as yours.

Other Medicines and Morphine Sulfate 2mg in 1mL Solution for Injection

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This is especially important if you are taking any of the medicines mentioned below or medicines for:

  • Rifampicin to treat e.g. tuberculosis
  • Concomitant use of Morphine sulfate 2mg in 1mL Solution for Injection and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe Morphine Sulfate 2mg in 1mL Solution for Injection together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
  • Are taking medicines to treat depression
  • Are taking medicines for sickness (phenothiazines), for drying secretions (anticholinergics e.g. hyoscine) or other pain killers
  • Have taken one of a group of drugs called monoamine oxidase inhibitors (used to treat depression) within the last two weeks
  • Are taking anti-psychotics, cimetidine, domperidone or metoclopramide
  • Are taking esmolol, mexiletine or ritonavir

Pregnancy

If Morphine Sulfate 2mg in 1mL Solution for Injection is used for a long time during pregnancy, there is a risk of the new-born child having drug withdrawal (abstinence) symptoms which should be treated by a doctor.

Driving and using machines

You must not use machinery whilst using this medicine. The medicine can affect your ability to drive as it may make you sleepy or dizzy.

  • Do not drive while taking this medicine until you know how it affects you.
  • It is an offence to drive if this medicine affects your ability to drive.
  • However, you would not be committing an offence if:
  • The medicine has been prescribed to treat a medical or dental problem and
  • You have taken it according to the instruction given by the prescriber or in the information provided with the medicine and
  • It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Morphine Sulfate 2mg in 1mL Solution for Injection contains Sodium Chloride

This medicine contains 3.6mg sodium (main component of cooking/table salt) in each mL. This is equivalent to 0.2% of the WHO recommended daily intake of 2g sodium for an adult.

  1. How to use Morphine Sulfate 2mg in 1mL Solution for Injection

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The doctor will decide what dose of this medicine you should be given. It will need to be given by a nurse or doctor using a syringe and needle to draw up the injection for administration.

The syringe may be put into a small machine which allows a slow continuous injection of this medicine to be given.

There is a procedure called Patient Controlled Analgesia (PCA) where you will be provided with a button to press when you are in pain and the machine will then give you a small amount of this medicine. There will be a safety device on the machine so that you cannot exceed the maximum number of doses.

Let your doctor or nurse know if your pain gets worse while you are using this medicine. Your doctor may want to increase your dose of the medicine and/or give you some extra medicines for the pain.

If you use more Morphine Sulfate 2mg in 1mL Solution for Injection than you should:

Tell your doctor as soon as possible. If you are a medical practitioner administering this medicine please refer to the Summary of Product Characteristics.

People who have taken an overdose may get pneumonia from inhaling vomit or foreign matter, symptoms may include breathlessness, cough and fever. People who have taken an overdose may also have breathing difficulties leading to unconsciousness or even death.

If you forget to use Morphine Sulfate 2mg in 1mL Solution for Injection.

The dose should be given as soon as it is remembered. The next dose should be given at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop using Morphine Sulfate 2mg in 1mL Solution for Injection

Tolerance and dependence are likely to occur after long-term treatment, and you may experience withdrawal symptoms if you stop taking this medicine suddenly. If you are concerned that you are becoming dependent on this medicine, speak to you doctor.

Do not stop treatment with Morphine Sulfate 2mg in 1mL Solution for injection unless agreed with your doctor. If you want to stop the treatment with Morphine Sulfate 2mg in 1mL Solution for injection, ask your doctor how to slowly decrease the doses so you avoid abstinence symptoms. Abstinence symptoms may include body aches, tremors, diarrhoea, stomach pain, nausea, flu-like symptoms, fast heartbeat and large pupils. Psychological symptoms include an intense feeling of unsatisfaction, anxiety and irritability

  1. Possible side effects

Like all medicines, this medicine can cause side effects although not everybody gets them.

Important side effects or symptoms to look out for and what to do if you are affected:

  • Serious allergic reaction which causes difficulty in breathing or dizziness. If you are affected by these important side effects contact a doctor immediately.

The most common side effects are respiratory depression (slow or shallow breathing), nausea, vomiting, constipation, feeling more sleepy than normal and feeling confused.

Other common side effects are:

  • Muscle rigidity
  • Tachycardia (fast heartbeat)
  • Inability to concentrate
  • Postural hypotension (low blood pressure on sitting or standing)
  • Itchiness
  • Decreased effectiveness
  • Spasm of the tubes of the kidney, bladder or gallbladder
  • Hypothermia
  • Vertigo
  • Disorientation
  • Rash due to an allergic reaction in the skin
  • Agitation
  • Excitation
  • Sweating
  • Abstinence symptoms or dependence (for symptoms see section 3: If you stop taking Morphine Sulfate 2mg in 1mL solution for injection).
  • Feeling of sadness
  • Feeling of well being
  • Affected eye sight
  • Dizziness
  • Upset stomach or indigestion
  • Transient loss of consciousness
  • Abdominal pain
  • Pain and irritation at the injection site
  • Feeling unwell
  • Increased pressure inside the skull
  • Affects normal sleep
  • Rashes
  • Itchy rash of skin with raised bumps
  • An increased sensitivity to pain
  • Dry mouth

Tell your doctor, nurse or pharmacist immediately if you think you have any of these, or other problems.

LONG-TERM TREATMENT WITH THIS MEDICINE

Further side effects can occur during long-term treatment with this medicine. These side effects include:

  • Difficulty in urinating or unable to pass urine
  • Hallucinations
  • Colic
  • Contractions of the pupils
  • Dry mouth
  • Restlessness
  • Sweating/ facial flushing
  • Mood changes
  • Headache
  • Decreased libido
  • Palpitations
  • Disruption of the menstrual cycle
  • Slowed heartbeat
  • Reduced blood pressure
  • Spasm of the airways
  • Changes in taste
  • Fitting
  • Recurrence of pancreatitis
  • Uncontrolled movement of the eyes
  • Fluid retention
  • Increased blood pressure
  • Loss of weight due to poor eating
  • Total or partial bowel blockage
  • Muscle jerk
  • Muscle twitch
  • Infertility
  • Severe muscle pain
  • Difficulty in coughing
  • Depression
  • Lack of strength in muscles
  • Inability to obtain or sustain an erection of the penis
  • Decreased effectiveness
  • Increased sensitivity to the pain
  • Reduced adrenal gland function

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.

  1. How to store Morphine Sulfate 2mg in 1mL Solution for Injection

Keep this medicine out of the sight and reach of children. This medicine has an expiry date printed on the bottle (vial) and carton label. Before use the doctor or nurse will check the product has not passed this date and that the medicine does not show any sign of deterioration. The expiry date refers to the last day of the month.

After the expiry date return any unused medicine to a pharmacy.

Store this medicine away from sunlight and below 25°C.

  1. Contents of the pack and other information

What Morphine Sulfate 2mg in 1mL Solution for Injection contains:

  • The active substance is Morphine Sulfate at a strength of 2mg in 1mL.
  • The other ingredients are Sodium Chloride and Water for Injections.

What Morphine Sulfate 2mg in 1mL Solution for Injection looks like and contents of the pack:

This medicine is a clear and colourless or almost colourless solution. This medicine is available in 50mL single use vials. The medicine is packed into cartons containing one vial or 10 vials. Both pack sizes may not be available at the same time.

 

  1. 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