Papaverine Hydrochloride Injection USP 30mg/ml Taj Pharma

Papaverine Hydrochloride Injection USP 30mg/ml

1.         NAME OF PRODUCT

Papaverine Hydrochloride 30mg/ml Solution for injection USP Taj Pharma
Papaverine Hydrochloride 60mg/2ml Solution for injection USP Taj Pharma

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains
Papaverine hydrochloride USP              30mg

Each 2ml contains
Papaverine hydrochloride USP              60mg

For the full list of excipients, see section 6.1.

3.         PHARMACEUTICAL FORM

Solution for injection
The pH of the injection ranges between 3.0 and 5.0.

  1. CLINICAL PARTICULARS

4.1Therapeutic indications

Papaverine Hydrochloride Injection is indicated for  the  treatment  of  erectile dysfunction.

3.2   Dose and method of administration

Papaverine Hydrochloride Injection should  only  be  prescribed,  and  treatment  should be supervised, by prescribers having expertise in the management of erectile dysfunction using a range of treatment modalities.

The 300mg/10 mL ampoule of   Papaverine Hydrochloride  Injection must only be  used for treatment of a single patient, on one occasion only.

The use of Papaverine Hydrochloride Injection in combination with other agents, including phentolamine and alprostadil is not recommended (see section 4.4).

Papaverine Hydrochloride Injection should be administered by  intracavernosal injection.

Before initiation of treatment with  Papaverine Hydrochloride Injection, patients should be carefully assessed by a specialist practitioner in erectile dysfunction with appropriate training in the use of this drug. The dose should be titrated carefully according to individual need. The first injection of  Papaverine Hydrochloride Injection must be done by  medically trained personnel. After proper training and instruction,  Papaverine Hydrochloride Injection may be  injected  at  home.  If  self-administration  is planned, the specialist should make an assessment of the patient’s (or as appropriate, the partner’s) skill and competence with the procedure. While on self-injection treatment, it is recommended that the patient visit the  specialist’s  office  at  periodic  intervals.  At  that  time, the efficacy and safety of the therapy should be assessed, and the dose of  Papaverine Hydrochloride Injection should be adjusted, if needed.

Dosage

The lowest effective dose should be determined for each patient. In general most patients respond to doses in the range of 2.5 to 60mg of papaverine hydrochloride.

A starting dose of 15mg is recommended for patients with erectile dysfunction due to most causes. Patients with psychogenic erectile dysfunction are likely to respond to lower doses,  while those with vasculogenic erectile dysfunction  are likely to require higher doses.  Patients who do not respond to a dose of 60mg should be changed to alternative therapy.

A starting dose of 5mg is recommended for men with erectile dysfunction due to spinal cord injury.

Erection usually occurs within 10 minutes of injection of the drug and may persist for one to several hours. Tolerance to papaverine hydrochloride may occur  during  long-term use and  may require an increase in dosage.

The dose should be reduced if erections persist  for  longer  than  four  hours. Early studies using doses of up to 80mg papaverine hydrochloride resulted in high proportion patients requiring assisted detumescence.

Dosage adjustment should be made carefully, based on the degree and duration of tumescence achieved with the previous dose.

General procedure for injection

 Ampoules of  Papaverine Hydrochloride Injection are intended for single use only and should be discarded after use. The  300mg/10  mL ampoule  is  for use in one  patient only, on one occasion only.

Intracavernosal papaverine hydrochloride may be self-administered by patients, but only after careful training in the technique to reduce the incidence of inadvertent subcutaneous administration, ecchymosis and urethral injury.

The patient should be instructed to use a new syringe and needle for each injection and in the appropriate disposal of the syringe and the needle. Needle breakage, with a  portion  of  the needle remaining in the penis, has  been reported and in  some  cases, required  hospitalisation  and surgical removal. The patient should be cautioned against using  bent  needles, to inject  Papaverine Hydrochloride Injection or attempting to straighten a bent needle prior to injecting.

 

Following is the general procedure for injection.

  1. Prior to administration, visually inspect Papaverine Hydrochloride Injection for particulate matter and
  2. Using a needle, withdraw the required A 13 mm, 27 to 30 gauge needle is recommended.
  3. Stretch the penis out across the thigh, with the foreskin retracted in uncircumcised Clean the  site   with  an alcohol swab. Do  not  inject  along the  midline. Do not inject through any of the  superficial veins  that are clearly visible  under the  skin. Inject over one  to two minutes into either of the two corpora  cavernosa.  Inject at 90 degrees to the  skin; the needle should be inserted up to the needle hub  to ensure that the corpus  is  injected. Note:   Subsequent  injections   should   be  alternated  between  the two  cavernosa. The injection site should be varied from the base of the penis to just proximal to  the  glans avoiding the midline and any veins.  Injections  should  not  be  made  into  the  underside  of the penis.
  4. After injecting, remove the needle and apply pressure to the injection site with the alcohol swab until any bleeding The entire length of the corpus cavernosum should be squeezed firmly to distribute medication, followed by the same procedure on the other side. The penis should then be pinched transversely in several places to distribute medication to both ends of the corpus cavernosum. This procedure should result in an erection that is adequate for intercourse.

 

3.3   Contraindications

Papaverine Hydrochloride Injection is contraindicated in patients with complete atrioventricular block.

Papaverine Hydrochloride Injection is contraindicated in patients  who have  conditions that might predispose them to priapism such as sickle cell anaemia, multiple myeloma or leukaemia. Patients with pre-existing penile fibrosis should not be accepted into intracavernosal self-injection therapy.   Papaverine Hydrochloride  Injection  should  not be used in patients with anatomical deformation of the penis, such as angulation, cavernosal fibrosis or Peyronie’s disease.

Papaverine Hydrochloride Injection should not be used in men for whom sexual activity is inadvisable or contraindicated.

Papaverine Hydrochloride Injection should not  be  used  in  patients  with  penile implants.

 

3.4   Special warnings and precautions for use

Priapism

 

Intracavernosal injection of  Papaverine Hydrochloride Injection has caused priapism. Treatment of priapism should not be delayed. Patie nts should be instructe d to seek urge nt me dical atte ntion if an erection lasts for more than four hours. Priapism has been managed by aspiration of cavernosal blood  and/or  intracavernosal injection of  small doses of an α-adrenergic agonist. Parenteral administration of high doses may cause cardiac arrhythmia and fatal apnoea;  a  slow  rate  of  intravenous administration is  recommended (over a 1 to 2 minute period) to avoid serious adverse effects.

Penile Fibrosis

Patients should be carefully assessed for pre-existing penile fibrosis before initiation of treatment with intracavernosal Papaverine Hydrochloride Injection. If  pre-existing  penile fibrosis is found, the patient should not be  accepted into intracavernosal self-injection therapy. This assessment should be made  during  pharmacologically-induced  erection.  At regular visits, the physician must examine the penis carefully, preferably in the erect state, for potential development of fibrotic changes. If there are  signs of  fibrotic  complications, treatment with  Papaverine Hydrochloride Injection must be stopped immediately. Development of penile fibrosis  appears  to be  related to the  injection  volume  being  in  excess of 1 mL. During self-injection therapy, the  patient must be instructed to report to the physician any unusual new adverse effects such as increased or  new  penile  pain,  penile bending and/or nodule formation in the penile shaft.

Other Precautions

Caution is also advised  in the presence of cardiac conduction disorders or unstable cardiovascular disease. Extreme care should be taken when conduction is depressed since the drug may produce transient ectopic rhythms of ventricular origin, either premature beats or paroxysmal tachycardia. Elderly patients should undertake  an ECG before  being  prescribed this product to eliminate the existence of cardiac conduction disorders.

Patients on anticoagulants such as warfarin or heparin may have an increased propensity for bleeding after the intracavernosal injection.

The injection of papaverine hydrochloride  can  induce  a  small amount  of  bleeding  at the  site of injection. In patients infected with blood-borne diseases, this could increase the transmission of such diseases to the partner.

Patients should be advised to take care when getting up  from a  lying  or  sitting  position or when climbing stairs because of the possibility of postural hypotension.

Combination Therapy 

The physical compatibility and stability of papaverine hydrochloride with alprostadil and/or phentolamine in mixed preparations has not been  established. Co-administration  of papaverine hydrochloride with alprostadil and/or phentolamine was associated with an increased risk of adverse events including dizziness and  syncope  in  evaluated  trials.  The safety and efficacy of combination therapy with papaverine hydrochloride and phentolamine and/or alprostadil has not been established.

The use of papaverine hydrochloride in combination  with oral agents for  erectile  dysfunction has not been established.

Use in Hepatically Impaired Patients 

Papaverine Hydrochloride Injection should be used with caution in patients with pre- existing hepatic impairment (liver disease) because of the potential for exacerbation (see below). If signs or symptoms of exacerbated hepatic impairment occur during papaverine hydrochloride therapy, the drug should be discontinued.

Liver Function Abnormalities

Elevations of hepatic  enzymes and bilirubin have been reported during use of papaverine hydrochloride. Most of the affected patients were also consuming alcohol and a causal relationship to papaverine hydrochloride has not been proven. Routine monitoring of hepatic function during papaverine hydrochloride therapy is not required. However, patients with a history of alcohol abuse or liver disease should  be  followed more  closely with liver  function tests obtained before initiating treatment and at 6-monthly intervals.

Effect on Laboratory Tests

Liver function test results  (serum ALT, AST and bilirubin concentrations  as  well  as eosinophil count) may be altered during intravenous papaverine hydrochloride therapy.

3.5   Interaction with other medicines and other forms of interaction

The effects of  Papaverine hydrochloride  may be  slightly  potentiated  by CNS depressants and a synergism may result from combination with morphine.

Papaverine hydrochloride may interfere with the therapeutic effects  of  levodopa  in  patients with Parkinson’s disease when the drugs are administered concomitantly.  Several  Parkinsonian patients maintained on levodopa have developed worsening of their Parkinsonism   following  Papaverine hydrochloride   administration.   The  therapeutic  response to levodopa returned 5 to 10 days after the papaverine was stopped. The use of papaverine hydrochloride in these patients should be avoided.

Patients on anticoagulants such as warfarin or heparin may have an increased propensity for bleeding after the intracavernosal injection.

Ioxaglate can form a  paste-like  precipitate  with  Papaverine hydrochloride,  and  this  could have serious consequences should precipitation occur in the penis.

3.6   Fertility, pregnancy and lactation

Fertility

There are no adequate human or animal studies addressing the effect of papaverine hydrochloride on fertility or reproductive performance.

Pregnancy

Category B3

Papaverine Hydrochloride Injection is not intended for use by women.

In animal studies, a single 140mg/kg subcutaneous  dose  of papaverine hydrochloride  to mice  on gestation day 9 (timed to coincide with neural tube closure) caused increased foetal mortality and retardation, spinal cord kinking and dilation  of  the  fourth  brain  ventricle.  Neither neural anomaly was observed in control foetuses. Neural tube defects were also observed in explanted mouse and chick embryos exposed to 50-75 microgram/mL papaverine hydrochloride during neurulation in vitro.The  relevance  of  these  animal findings  to humans is currently unknown.

There are no formal studies of papaverine hydrochloride in pregnant women.

Lactation

Papaverine hydrochloride Injection is not intended for use by women.

It is not known whether papaverine hydrochloride is excreted in breast milk. Because many drugs are excreted in  breast  milk, caution should be  exercised when Papaverine hydrochloride is administered to a nursing woman.

3.7   Effects on ability to drive and use machinery

No data available.

3.8   Undesirable effects

Intracavernosal injection of papaverine hydrochloride may cause mild discomfort in the penis during injection, ecchymosis  at the  injection site,  urethral  bleeding,  paraesthesia  of   the glans, difficulty in reaching orgasm and ejaculation, and priapism. Treatment of priapism should not be delayed. Patients should be instructed to seek urgent medical attention if an erection lasts for more than four hours.

Following is a listing of local and systemic adverse effects from  clinical  studies  and  case reports in which papaverine hydrochloride was used.

Local Adverse Events

  • Prolonged erection/priapism
  • Penile fibrosis, manifested as subcutaneous nodules, plaques, cavernosal fibrosis, scarring, deformity, curvature (Peyronie’s disease) and calcification
  • Pain/ discomfort/ burning sensations during the injection
  • Injection site bruising/ haematoma
  • Injection site blister/ ulcer
  • Penile/ foreskin oedema
  • Loss of penile sensation
  • Misplaced injections, sometimes leading to urethral bleeding
  • Pain during erection
  • Infection/ cavernositis/ pyogenic granuloma
  • Thrombophlebitis/ lymphangitis
  • Intracorporal needle breakage
  • Fixed drug eruption
  • Penile fracture

Systemic Adverse Events

  • Liver function abnormalities
  • Symptoms/ signs  resulting  from  vasodilation  including  headache,  flushing,   a sensation of  heat in the pelvis, dizziness, photopsia, tachycardia, hypotension and
  • Vasovagal reactions
  • Cardiac events
  • Allergic reactions, urticaria
  • Impaired ejaculation
  • Death (one report)

Re porting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the  medicine is  important.  It allows continued monitoring of the benefit/risk balance of the medicine.

3.9   Overdose

Symptoms

 

The symptoms of toxicity from papaverine hydrochloride often result from vasomotor instability and include nausea, vomiting, weakness, central nervous system depression, nystagmus, diplopia, diaphoresis, flushing,  dizziness, and  sinus tachycardia.  In  large overdoses, papaverine hydrochloride is a potent inhibitor of cellular respiration and a weak calcium antagonist. Following an oral overdose  of 15 g, metabolic acidosis with hyperventilation, hyperglycaemia, and hypokalemia have been  reported.  No  information  on toxic serum concentrations is available.

Overdose of papaverine hydrochloride via the intracavernosal route is likely to result in priapism. Patie nts should be instructed to seek urgent me dical atte ntion if an erection lasts for more than four hours.

Patients should be instructed to seek medical help  immediately  if  they have self-administered an overdose of papaverine hydrochloride.

Treatment

In managing overdosage, a physician must consider   the  possibility  of   multiple  drug  overdoses, interaction among drugs, and unusual drug kinetics.

The patient’s airway must be protected, and ventilation and perfusion supported. Vital signs, blood gases, blood chemistry values and other variables need to be monitored.

In the event of convulsions, administration  of  diazepam or  phenytoin  needs  to be  considered. If seizures are refractory, general anaesthesia with thiopentone or  halothane  and  paralysis with a neuromuscular blocking agent may be necessary.

For hypotension, intravenous fluids, elevation of  legs and administration of an inotropic vasopressor, such as dopamine, need to be considered.  Theoretically, calcium gluconate  may be helpful in treating some  of  the  toxic  cardiovascular  effects  of  Papaverine hydrochloride; the ECG and plasma calcium concentrations need to be monitored.

5.   PHARMACOLOGICAL PROPERTIES

  • Pharmacodynamic properties

Mechanism of action

Papaverine hydrochloride is the hydrochloride of an alkaloid obtained from opium or prepared synthetically. It belongs to the benzylisoquinoline group of alkaloids. The principal therapeutic action of papaverine hydrochloride is its relaxant effect on smooth muscles, which leads to penile erection. It may  induce  erections  by  arteriolar  relaxation,  increased blood flow and volume due to relaxation of the sinusoidal wall of the corpora cavernosa and subsequent compression of venous channels between the sinusoids and the tunica albuginea.

The spasmolytic effect of papaverine hydrochloride is most pronounced on the vascular system, including coronary, cerebral, pulmonary  and  peripheral  vasodilation;  it  also  relaxes the bronchial, gastrointestinal, biliary and urinary tract smooth muscles.  Papaverine hydrochloride has also been reported to have direct cardiac inotropic effects, leading  to increased myocardial oxygen consumption, which can outstrip the effect of increased coronary blood flow if hypotension is also present. It can depress  myocardial  excitability, prolong the  refractory period and depress myocardial conduction. In the  presence  of  depressed conduction due to other causes (eg AV block), Papaverine hydrochloride  may produce transient ventricular arrhythmias. Papaverine hydrochloride can mildly stimulate respiration via action on the carotid and aortic body chemoreceptors.

Papaverine hydrochloride has minimal Central Nervous System (CNS) actions, although large doses may have a depressant effect in some patients. The drug also exhibits weak calcium-channel blocking activity at high doses.  Papaverine hydrochloride  has  been reported to have antiviral activity against  respiratory syncytial  virus,  cytomegalovirus,  measles  and HIV. It may inhibit mitochondrial oxidative reactions,  which  can lead to severe lactic acidosis following large doses, especially overdose.

5.2      Pharmacokinetic properties

The extent and time-course of papaverine hydrochloride absorption have not been documented. In theory,  systemic  absorption following intracavernosal injection would initially be rapid, until the local effect of papaverine hydrochloride led to occlusion of  the  venous outflow from the penis. Absorption would then be slow, but would pick up again as detumescence occurred and the sequestered blood was returned to the systemic circulation.

Papaverine hydrochloride has a relatively short plasma half-life (1-2 hours) and is rapidly metabolised by the liver and excreted in the urine, chiefly as the glucuronide conjugates of phenolic metabolites. The drug is  excreted in  the  urine  in  an inactive  form. Approximately 90% of  the drug is bound to plasma proteins. After intracavernosal injection, the peak plasma concentration is several times lower than after extracavernosal injection.

5.3      Preclinical safety data

Genotoxicity

In an Ames test, papaverine hydrochloride was weakly mutagenic to the TA100 but not the TA98 strain of Salmonella typhimurium, only in the presence of metabolic activation.

Carcinogenicity

No long-term animal studies on the carcinogenic potential of papaverine hydrochloride  have  been performed.

Re productive and developmental toxicity

There are no adequate human or animal studies addressing the effect of papaverine hydrochloride on fertility or reproductive performance.

6. PHARMACEUTICAL PARTICULARS

  • List of excipients

Water for injection

6.2      Incompatibilities

A precipitate results when  Papaverine Hydrochloride Injection is added to lactated Ringer’s Injection.

6.3      Shelf life

36 months

6.4      Special precautions for storage

Papaverine Hydrochloride Injection should be stored below 25°C and protected from light.

6.5      Nature and contents of container

Papaverine Hydrochloride Injection is supplied in  clear  glass  ampoules  in  the following presentations and pack sizes:

Papaverine hydrochloride  Injection 30mg/1 mL  5 x 1 mL, 2ML ampoules

  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

 

 

 

                    Papaverine Hydrochloride Injection USP 30mg/ml, 60mg/2ml  

 

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking 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 or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

 

What is in this leaflet:

  1. What Papaverine Hydrochloride Injection is and what it is used for
  2. What you need to know before you are given Papaverine Hydrochloride Injection
  3. How Papaverine Hydrochloride Injection is given
  4. Possible side effects
  5. How to store Papaverine Hydrochloride Injection
  6. Contents of the pack and other information

What is in this leaflet

This leaflet answers some common questions about  Papaverine Hydrochloride Injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor weighed the risks of you using papaverine against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet.

You may need to read it again.

What  Papaverine Hydrochloride Injection is used for

This medicine is used to produce erections in impotent men. It belongs to a group of medicines called vasodilators.

When papaverine is injected into the penis (called ‘intracavernosal’ injection) it works by increasing blood flow to the  penis, which results in an erection. Ask your doctor if you have any questions about why this product has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is not addictive.
This medicine is available only with a doctor’s prescription.

There is not enough information to recommend the use of this medicine for children and newborn babies.

Before you use  Papaverine Hydrochloride Injection

When you must not use it

Do not use  Papaverine Hydrochloride Injection if you have an allergy to:

  • any medicine containing papaverine
  • any of the ingredients listed at the end of this leaflet.

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; rash, itching or hives on the skin.

Do not use this medicine if you have any of the following medical conditions:

  • complete atrioventricular block (a heart condition characterised by a
  • slow or irregular heart beat)
  • sickle cell anaemia (a disease in
  • which the amount of oxygencarrying
  • pigment in the blood is
  • below normal and the red blood
  • cells become distorted)
  • leukaemia (cancer of the blood)
  • multiple myeloma (cancer of the
  • bone)
  • an implant in your penis
  • any deformities of the penis
  • abnormal thickening of the tissue
  • of the penis
  • any condition where sexual
  • activity is inadvisable.

 

Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for

disposal. If you are not sure whether you should start using this medicine, talk to your doctor.

Before you start to use it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

 

Tell your doctor if you have or have had any of the following medical conditions:

  • heart problems
  • liver disease
  • any disease that may be transmitted by contact with blood.

Tell your doctor if you are taking any oral medications used to treat impotence in men.

If you have not told your doctor about any of the above, tell him/her before you start to use papaverine.

Taking other medicines Tell your doctor or pharmacist if you are taking or using any other medicines, including any that you get without a prescription fromyour pharmacy, supermarket or

health food shop. Some medicines and papaverine may interfere with each other. These include:

  • levodopa, a medicine used in the treatment of Parkinson’s disease
  • medicines to strong relieve pain, such as morphine, or other medicines which cause sleepiness
  • medicines used to prevent blood clots, such as warfarin and heparin
  • ioxaglate, a dye used when taking x-rays of the penis.

These medicines may be affected by

papaverine, or may affect how well it works. You may need different amounts of your medicine, or you may need to take/use different

medicines. Your doctor and pharmacist may

have more information on medicines to be careful with or avoid while using this medicine.

How  Papaverine Hydrochloride Injection

is given

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much is given

Your doctor will decide what dose of papaverine you will receive. This depends on your medical condition and whether or not you are taking

any other medicines.

How it is given

A doctor or nurse will show you how to do the injection for at least the first time. If you will be self administering papaverine your doctor will provide you with proper training and instruction to ensure that administration related injuries do not

occur.

It is important that you follow your doctor’s instructions at all times. If you are not certain about the way this medicine is given please contact your doctor; this leaflet is only intended to remind you about the instructions your doctor has already given you.

Always use a new syringe and needle for each injection. A 13 mm 27 to 30 gauge needle is

recommended.

If the needle is bent at any time, do not use it for injecting papaverine and do not attempt to straighten it before injecting papaverine. A bent

or restraightened needle may be more likely to break. Needle breakage with a portion of the needle remaining in the penis has been reported and in some cases requires hospitalisation and

surgical removal. Do not use papaverine if the

ampoule is damaged or if the solution looks cloudy, coloured, or has particles in it.

Stretch the penis out across the thigh. If you are uncircumcised the foreskin must be pulled back

before you inject papaverine. Clean the injection area with an alcohol swab.

Papaverine is injected directly into the base of the penis on the left or right-hand side. It is given as a

slow injection over 1 to 2 minutes.

Papaverine should not be injected

just under the skin or into the

midline or lower part of the penis.

After you have completed the injection, put pressure on the place of injection to prevent bruising.

Then massage your penis as instructed by your doctor. This helps the medicine spread to all

parts of the penis, so that it will work better.

Do not re-use or share needles or syringes.

Papaverine normally begins to work in about 10 minutes and the erection may persist for one to several hours.

If you use too much (overdose)

In case of overdose, immediately contact the

go to Accident and Emergency at your nearest

hospital, if you think that you or anyone else may have used too much papaverine. Do this even if

there are no signs of discomfort or poisoning.

You may need urgent medical attention. Symptoms of an overdose may include nausea, vomiting, weakness, drowsiness, double vision, rapid uncontrollable movements of the eyes, sweating, flushing, dizziness, increased heart rate or priapism (a persistent painful erection of the

penis that does not reverse within four hours).

While you are using Papaverine Hydrochloride Injection

Things you must do

Do not injection this medicine under the skin or into the midline or lower part of the penis. If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using papaverine.

Tell any other doctors, dentists, and pharmacists who are treating you that you are using this

medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are using this medicine.

It may affect other medicines used during surgery.

 

If you are about to have any blood tests, tell your doctor that you are using this medicine. It may interfere with the results of some tests.

 

Contact your doctor immediately if the erection lasts for longer than 4 hours, or if it becomes painful.

This may be a sign of priapism and must be treated immediately to prevent permanent damage.

Keep all of your doctor’s appointments so that your progress can be checked.

 

Examine your penis regularly and contact your doctor if you notice changes or experience bleeding that does not stop despite applying

pressure on the site. Things to look out for include a lump where papaverine has been injected, or

your penis becoming curved. These may be signs of fibrosis (abnormal thickening of tissue).

Things you must not do

Do not use papaverine to treat any other complaint.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not increase the dosage of your medicine or use it more frequently than your doctor has instructed.

If too much is used, the erection may become so strong that it lasts too long and does not reverse when it should.

Do not use any solution left in the ampoule for a second injection, it should be used on one occasion only. Discard any solution that is

left over.

Do not use the needle to inject if it is bent.

Things to be careful of

Be careful driving or operating machinery until you know how papaverine affects you.

This medicine may cause dizziness, and drowsiness in some people. If you have any of these symptoms, do not drive, operate machinery or do

anything that could be dangerous.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.

Standing up slowly, especially when you get up from bed or chairs, will help your body get used

to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel well while you are using papaverine.

This medicine helps most people with impotence, but it may have unwanted side effects in a few

people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get

some of the side effects.

Do not be alarmed by the following lists of side effects.

You may not experience any of them.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • dizziness, headache or flushing
  • mild discomfort in the penis during injection
  • bruising or bleeding at injection site
  • blood appearing at the end of the penis
  • tingling at the tip of the penis difficulty in ejaculating.The above list of side effects are usually mild and short-lived.

Tell your doctor as soon as possible if you notice any of the following:

  • pain or burning along penis
  • redness and swelling at the injection site
  • fibrosis (lumps) in the penis
  • bending of the penis
  • blister or ulcer at injection site
  • swelling of the penis or foreskin.

The above list includes serious side effects which may require medical attention.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • increase in heart rate
  • erection that lasts for more than 4
  • hours
  • painful erection
  • yellowing of the eyes and/or skin
  • (jaundice).

These are very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may occur in some patients.

After using  Papaverine Hydrochloride Injection

Storage

Keep your medicine in the original pack until it is time to use it.

If you take your medicine out of the pack it may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 25°C. Protect from light.

Do not store papaverine or any other medicine in the bathroom or near a sink. Do not leave it on a

window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and a- half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description
What it looks like  Papaverine Hydrochloride

Injection is a clear colourless or pale

yellow solution in a glass ampoule.

Ingredients

Active ingredients:

  • papaverine hydrochloride

Other ingredients:

  • water for injections.
  • benzyl alcohol (only in the

300mg/10mL presentation).

This medicine does not contain gluten, lactose, sucrose, tartrazine, or

any other azo dyes.

Papaverine Hydrochloride

Injection is available in the following

strengths and pack sizes:

  • 30 mg/1 mL ampoules

(packs of 5)

 

  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