Takipril – Prilocaine hydrochloride uses, dose and side effects

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20 mg/ml solution 

for injection
prilocaine hydrochloride

What Takipril is and what it is used for

Takipril 20 mg/ml is a type of medicine called a local anesthetic, belonging to the amide group, and is a solution for injection. Takipril is used in adults to numb specific body parts and prevent pain during surgery.

Takipril is injected into the lower part of the spine. This quickly stops pain from the waist down for a limited time (short-term surgical procedures).

Prilocaine hydrochloride contained in Takipril may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you receive Takipril

Takipril must not be given to you

  • if you are allergic to prilocaine hydrochloride, other amide-type local anesthetics, or any of the other ingredients of this medicine (listed in section 6),
  • if you have serious conduction problems in the heart,
  • if you suffer from severe anemia,
  • if you have untreated heart failure,
  • if you are in shock because the heart’s pumping ability fails and the amount of blood in the body is too little,
  • if you suffer from congenital or acquired methemoglobinemia,
  • if there are general or specific conditions or factors that make the technique used in spinal anesthesia inappropriate.

Takipril must not be injected into a blood vessel.

Takipril must not be used in children younger than 6 months.

Warnings and precautions

Talk to your doctor before receiving Takipril:

  • if you have had a severe reaction to an anesthetic in the past
  • if you have a skin infection at or near the proposed injection site
  • if you suffer from any of the following:
    • diseases of the central nervous system such as meningitis, polio, and problems with your spinal cord due to lack of blood
    • severe headache
    • tumor in the brain, spine, or other tumors
    • tuberculosis of the spine
    • recently had an injury to the spine
    • very low blood pressure or low blood volume in the body
    • problems with the blood’s ability to clot
    • acute porphyria
    • fluid in the lungs
    • blood poisoning
  • if you have problems with the heart (e.g. total or partial heart block, heart failure, rhythm disturbances)
  • if you have liver or kidney problems
  • if you suffer from a neurological disease, such as multiple sclerosis, unilateral paralysis, bilateral paralysis, or neuromuscular diseases
  • if you have a reduced general condition.

Spinal anesthesia may only be given by doctors with sufficient knowledge and experience. The attending physician is responsible for taking the necessary measures to avoid injection into a blood vessel and to be able to recognize and treat side effects.

Children and young people

Takipril is not recommended for children and adolescents. Takipril’s safety and efficacy in children and adolescents have not been established. No data is available.

Takipril must not be given to children younger than 6 months due to increased risk of developing methemoglobinemia.

Other medicines and Takipril

Tell your doctor if you are taking, have recently taken or might be taking any other medicines, even those without a prescription. This is especially true if you are taking medicines for irregular heart rhythm (class III antiarrhythmics ) and pain.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before receiving this medicine. Your doctor will decide if you can receive an injection of Takipril. Prilocaine should not be given for local or regional anesthesia during labor.

It is not known whether prilocaine passes into breast milk. Breastfeeding can be resumed approximately 24 hours after treatment.

Driving ability and use of machinery

Do not drive or work with tools or machines as Takipril may temporarily affect your ability to react and muscle coordination.

You yourself are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects . Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.

Taquipril contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose (maximum dose of 4 ml Takipril solution for injection ), i.e. it is almost “sodium-free”.

How Takipril is used

You will be given this medicine by your doctor, who will decide which dose is correct for you.

The usual dose for adults is 40-60 mg prilocaine hydrochloride (2-3 ml Takipril). The maximum dose is 80 mg prilocaine hydrochloride (4 ml Takipril).

The doctor will give you Takipril in the lower part of your spine while you are sitting or lying down.

Takipril is not recommended for children and adolescents. Takipril’s safety and efficacy in children and adolescents have not been established.

Takipril must not be given to children younger than 6 months due to increased risk of developing methemoglobinemia.

In patients with impaired general condition and with diagnosed concomitant diseases (e.g. blockage of blood vessels, arteriosclerosis, disease of peripheral nerves caused by diabetes (diabetic polyneuropathy ), a dose reduction is necessary.

In case of reduced liver or kidney function, a lower dose level is recommended.

Takipril is injected into the spinal fluid.

Equipment, drugs and personnel capable of dealing with an emergency must be in the immediate vicinity. Rare cases of serious reactions have been reported following the use of local anesthetics, even in patients who have not previously suffered from hypersensitivity.

If you have received too much Takipril

The doctor who gives you Takipril is experienced in giving local anesthetic to the spinal cord, so it is unlikely that you will get an overdose. Should a dose be accidentally injected directly into the bloodstream, you may experience short-term vision or hearing problems, muscle twitching, tremors, tremors, convulsions (seizures) and loss of consciousness. When you receive Takipril, there will be equipment available to treat you if an overdose occurs.

If you have any further questions about this medicine, ask your doctor or pharmacist.

Possible side effects

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

As with all local anesthetics, arterial pressure may drop and heart rate may slow.

You may feel nauseous, have low blood pressure or a slower heartbeat. Other possible side effects are headache after surgery, vomiting and difficulty urinating.

Possible side effects are:

Very common: may affect more than 1 in 10 users

Lowered blood pressure , nausea

Common: may affect up to 1 in 10 users

Numbness, dizziness, vomiting

Uncommon: may affect up to 1 in 100 users

Cramps, numbness around the mouth, unconsciousness, tremors, numbness of the tongue, speech difficulties, hearing problems, tinnitus , visual disturbances, back pain, temporary muscle weakness. Slow heartbeat, increased blood pressure .

Rare: may affect up to 1 in 1,000 users

Methemoglobinemia (a disorder in the blood’s ability to absorb oxygen and release carbon dioxide ), reduced oxygenation of the blood with bluish skin, and lips (cyanosis). Anaphylactic shock , anaphylactic reactions, allergic reactions, itching . Inflammation of the membranes surrounding the spine (arachnoiditis), numbness or weakness in the arms and legs ( neuropathy ), damage to peripheral nerves.

Double vision. Cardiac arrest, irregular heartbeat. Impaired respiratory function.

Takipril is unlikely to cause serious side effects unless it is accidentally given in the wrong way or used with other local anaesthetics. If this happens, numbness of the tongue, clouding, dizziness, tremors and convulsions may occur. In extremely rare cases, prilocaine has been associated with heart attack, difficulty breathing, loss of sensation in the lower part of the body and allergic reactions, which may cause skin rash, swelling or very low blood pressure .

A rare but serious side effect of spinal anesthesia is a high or complete spinal cord blockade, which leads to severely reduced cardiovascular and lung function.

How to store Takipril

Keep this medicine out of the sight and reach of children.

Use before the expiry date stated on the ampoules and carton after EXP. The expiration date is the last day of the specified month.

Store at a maximum of 25 ºC. Store protected from cold. Do not freeze.

Store in the original packaging. Light sensitive.

Use immediately after opening.

Takipril must not be used if the solution is not clear and free of particles.

Leftover medicine should be thrown away. As the medicine is only given in hospital, the hospital takes care of the destruction. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

The active substance is prilocaine hydrochloride.
1 ml solution for injection contains 20 mg prilocaine hydrochloride (equivalent to 2%).
1 ampoule with 5 ml of solution contains 100 mg of prilocaine hydrochloride.

Other ingredients are:

Anhydrous glucose or glucose monohydrate

Sodium hydroxide 1N (for pH adjustment)

Water for injections

Appearance and package sizes of the medicine

Solution for injection . Clear colorless solution.

Takipril solution is supplied in clear, colorless glass ampoules , type I.

Carton of 10 ampoules, each containing 5 ml solution for injection .

Marketing authorization holder and manufacturer

Marketing Authorisation Holder

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen

Germany

Mailing address:

34209 Melsungen, Germany

Manufacturer

Sirton Pharmaceuticals SpA

Piazza XX Settembre 2

22079 Villa Guardia (CO)

Italy

Sintetica GmbH

Albersloher Weg 11

48155 – Münster

Germany

Agent : B. Braun Medical AB, Box 110,

182 12 Danderyd

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