Dolten: Indications, How to Use, Interactions, Side Effects and Contraindications

It belongs to a group of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). It works by reducing hormones that cause inflammation and pain in the body.

Similarly, dolten ophthalmic (for the eye) is available, used to relieve itchy eyes caused by seasonal allergies.

Dolten ophthalmic is also used to reduce swelling, pain, and burning or stinging after cataract surgery or corneal refractive surgery.

Indications

The patient should carefully consider the potential benefits and risks of dolten and other treatment options before deciding to use the drug.

The lowest effective dose should be used for the shortest time possible and consistent with the patient’s treatment goals.

For sharp odor in adult patients

Dolten is indicated for the short-term treatment (5 days or less) of acute or moderately severe pain requiring opioid-level analgesia, usually in a postoperative setting.

The total combined duration of use of dolten by injection and dolten by mouth should not exceed 5 days of use.

If it exceeds 5 days there is the possibility of increasing the frequency and severity of adverse reactions associated with the recommended doses.

Patients should be switched to alternative pain relievers as soon as possible, but treatment with dolten should not exceed the recommended days.

Dolten injection has been used in conjunction with morphine and meperidine and has shown an opioid-sparing effect.

How should it be used?

Dolten should be used as directed by a physician. You need to check the drug label for exact dosing instructions.

The dolten comes with an additional information sheet for the patient called a medication guide, the person should read it carefully and consult with a doctor any doubts that arise.

It is used orally and as an injectable form for the short-term relief (3 to 5 days) of moderately severe pain.

It is also used as eye drops to prevent and treat pain and swelling in the eye after eye surgery.

The drug is also given through the nose. Before using each bottle for the first time, it must be prepared, for this the patient must:

  • Remove the clear plastic cover and the blue plastic safety clip.
  • Keep the bottle at an arm’s length.
  • With your index and middle fingers on the top of the bottle and your thumb on the bottom of the bottle, press down evenly and release the pump 5 times.
  • The bottle is now ready to use.

To use this nasal spray which gently blows the nose, the patient must:

  • Sit up straight or stand up and lean your head slightly forward.
  • Place the tip of the spray container on your nose.
  • Make sure to point the container away from the center of your nose.
  • Breathe gently through the nostril and squeeze the spray can.
  • If the dose requires two sprays, the process should be repeated for the other nostril.
  • Replace the clear plastic cover after each use.

It is important to know that dolten is not for the treatment of mild to moderate or chronic pain (eg headache).

Contact with the eyes should be avoided. If this happens, the patient should rinse with water. If eye irritation occurs and persists for more than one hour, it is necessary to contact a doctor.

Each bottle contains a day’s supply of dolten. It is recommended to discard each bottle within 24 hours of opening it, even if it still contains any unused medicine.

If the patient misses a dose of and takes it regularly, they should take it as soon as possible.

If it is almost time for the next dose, the missed dose should be discarded and return to your regular dosing schedule. You should not take two doses at the same time.

Description

Each ml of dolten injection contains the following excipients:

  • Sodium chloride 4.35 mg.
  • Alcohol (equivalent to absolute alcohol).
  • Water for injections.

Dosage

The tablet presentation is recommended for short-term use only, that is, up to 7 days and is not recommended for chronic use.

Adults

  • It is recommended to take 10 mg every 4 to 6 hours as needed. Doses greater than 40 mg per day are not recommended.
  • For patients receiving a formulation change the total combined daily dose should not exceed 90 mg (60 mg patients with renal impairment and less than 50 kg).
  • In the previous case, the oral components should not exceed 40 mg on the day the formulation change is made.
  • Patients should be converted to oral therapy as soon as possible.

Elderly

  • The dose should be 60 mg, a longer dose interval is recommended, for example 6 to 8 hours.
  • The lower limit of the dosage range is recommended for patients over 65 years of age.

Dolten injection can be used as a single or multiple doses for the treatment of acute or moderately severe pain requiring opium-level analgesia, usually in the postoperative setting.

Hypovolaemia must be corrected before administration of dolten. Patients should switch to alternative pain relievers as soon as possible.

When administering dolten injection, two formulas are presented (IV and IM). The dolten IV should be given no less than 15 seconds and the endow IM given slowly and deep into the muscle.

The analgesic effect begins in approximately 30 minutes with a maximum effect in 1 to 2 hours after dosing. The duration of the analgesic effect is usually 4 to 6 hours.

It is important to know the recommended dose of each formula according to the patient.

Treatment of dolten IM:

  • In the elderly (65 years or older) with renal impairment and / or with a body weight less than 50 kg, the recommended dose is 30 mg.
  • For the elderly under 65 years the single dose of 60 mg.

Treatment of dolten IV:

  • In elderly people 65 years of age or older, with renal impairment and / or with a body weight less than 50 kg, the recommended dose is 15 mg.
  • For the elderly under 65 years the recommended single dose is 30 mg.

For multiple dose treatment in elderly 65 years or older, with renal impairment and / or with body weight 50 kg, the recommended dose is 15 mg every 6 hours (should not exceed 60 mg).

Patients under 65 years of age should receive a dose of 30 mg every 6 hours. The maximum daily dose should not exceed 120 mg.

For breakthrough pain, the dose or frequency of dolten injection should not be increased.

For children, the safety and efficacy of Dolten has not been studied in children under 16 years of age.

Interactions

Dolten slightly reduces the plasma protein binding of warfarin .

In vitro studies indicate that at the therapeutic concentration of salicylate, the binding of dolten is reduced from approximately 99.2 to 97.5%.

This represents a potential two-fold increase in unbound plasma dolten levels.

Dolten has been reported to reduce the diuretic response to furosemide in normovolemic individuals by approximately 20%.

Concomitant administration of dolten and probenecid results in decreased clearance of dolten and a significant increase in plasma levels of Dolten.

An increase in plasma lithium concentration has been reported due to inhibition of renal lithium clearance.

There have been some reports of elevated plasma lithium levels with dolten as well.

There are reports of a possible interaction of dolten and non-depolarizing muscle relaxants, leading to apnea.

Concomitant use of dolten and angiotensin converting enzyme inhibitors may increase the risk of renal failure, particularly in volume depleted patients.

Very few cases of seizures have been reported with concomitant use of dolten and antiepileptic drugs.

There have been reports of hallucinations when dolten is used concomitantly with psychoactive drugs.

In laboratory tests dolten inhibits platelet aggregation and may prolong bleeding time.

There are foods that reduce the speed of action but not the degree of absorption.

Side effects

Adverse reaction rates increase with higher doses of dolten. Professionals should be on the lookout for serious complications of treatment, such as:

  • Gastrointestinal ulceration.
  • Hemorrhage.
  • Postoperative bleeding.
  • Acute kidney failure.
  • Anaphylactic and anaphylactoid reactions.
  • Liver failure.

These NSAID-related complications can be serious in certain patients for whom dolten is indicated, especially when the drug is used inappropriately.

In patients taking dolten or other NSAIDs in clinical trials, the most commonly reported side effects in about 1% to 10% of patients are:

Body in general

  • Fever.
  • Infections
  • Sepsis.
  • Pallor.

Cardiovascular

  • Congestive heart failure
  • Palpitations
  • Tachycardia.
  • Syncope.

Dermatological

  • Alopecia.
  • Photosensitivity.
  • Urticaria.

Gastrointestinal

  • Anorexia.
  • Dry mouth.
  • Belching
  • Esophagitis.
  • However excesiva.
  • Gastritis.
  • Glossis.
  • Hematemesis.
  • Hepatitis.
  • Increased appetite
  • Jaundice.
  • Rectal bleeding.

Hematic and lymphatic

  • Equimosis.
  • Eosinophilia.
  • Epistaxis.
  • Leucopenia.
  • Thrombocytopenia

Metabolic and Nutritional

  • Weight change.

Nervous system

  • Abnormal dreams
  • Abnormal thoughts
  • Anxiety.
  • Asthenia.
  • Confusion.
  • Depression.
  • Euphoria.
  • Hallucinations
  • Hyperkinesia.
  • Inability to concentrate
  • Insomnia.
  • Nervousness.
  • Paraesthesia
  • Drowsiness.
  • Stupor.
  • Tremors
  • Vertigo.

Female reproductive system

  • Infertility

Respiratory system

  • Asthma.
  • Tos.
  • Dyspnoea.
  • Pulmonary edema.
  • Rhinitis.

Senses

  • Abnormal taste
  • Abnormal vision
  • Blurry vision.
  • Hearing loss.

Urogenital

  • Cystitis.
  • Disuria.
  • Hematuria.
  • Increased urinary frequency.
  • Interstitial nephritis.
  • Oliguria o poliuria.
  • Proteinuria.
  • Urinary retention.

Other reactions rarely observed by some patients are:

Body in general

  • Angioedema.
  • Death.
  • Hypersensitivity reactions such as anaphylaxis.
  • Anaphylactoid reaction.
  • Laryngeal edema.
  • Edema of the tongue.
  • Myalgia.

Cardiovascular

  • Arrhythmia.
  • Bradicardia.
  • Chest pain.
  • Redness
  • Hypotension
  • Myocardial infarction.
  • Vasculitis.

Dermatological

  • Exfoliative dermatitis.
  • Erythema multiforme.
  • Lyell’s syndrome.
  • Toxic epidermal necrolysis.

Gastrointestinal

  • Acute pancreatitis.
  • Liver failure.
  • Ulcerative stomatitis.
  • Exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn’s disease).

Hematic and lymphatic

  • Agranulocitosis.
  • Aplastic anemia.
  • Hemolytic anemia.
  • Lymphadenopathy
  • Pancytopenia
  • Postoperative bleeding from the wound (rarely requiring blood transfusion).

Metabolic and nutritional

  • Hyperglycemia
  • Hyperkalemia.
  • Hyponatremia.

Nervous system

  • Aseptic meningitis.
  • Seizures
  • Coma.
  • Psychosis.
  • Respiratory system
  • Broncoespasmo.
  • Respiratory depression
  • Pneumonia.

Senses

  • Conjunctivitis.

Urogenital

  • Flank pain with or without hematuria and / or azotemia.
  • Hemolytic uremic syndrome.

An observational, non-randomized, post-marketing study was conducted involving approximately 10,000 patients receiving dolten.

The study demonstrated that the risk of clinically serious gastrointestinal bleeding depended on the administered dose.

This was particularly true in elderly patients who received an average daily dose of more than 60 mg per day of dolten.

Contraindications

Dolten is contraindicated in patients:

  • With previously demonstrated hypersensitivity to dolten.
  • With active peptic ulcer.
  • With recent gastrointestinal bleeding or perforation.
  • With a history of peptic ulcer or gastrointestinal bleeding.
  • Who have experienced asthma, hives or allergic-type reactions after taking aspirin or other NSAIDs.
  • With advanced renal failure or in patients at risk of renal failure due to volume depletion.
  • Pregnant women since through its inhibitory effect on prostaglandin synthesis, it can affect fetal circulation and inhibit uterine muscles, thus increasing the risk of uterine bleeding.
  • With suspected or confirmed cerebrovascular hemorrhage, hemorrhagic diathesis, incomplete hemostasis and those at high risk of hemorrhage as it inhibits platelet function.
  • Currently receiving aspirin or NSAIDs due to the cumulative risks of inducing serious adverse events related to NSAIDs.

In its form of treatment, dolten is contraindicated:

  • As a prophylactic pain reliever before any major surgery.
  • For the treatment of perioperative pain in the context of coronary artery bypass grafting.
  • Concomitant use of Dolten SL Tromethamine and probenecid.
  • Concomitant use of Dolten SL Tromethamine and pentoxifylline.
  • Dolten SL Tromethamine injection for neuraxial (epidural or intrathecal) administration due to its alcohol content.