Artigo20 mg+40 mg

Artigo is a fixed-dose combination antihistamine/antivertigo preparation indicated for:

• Treatment of vertigo of various origins (e.g., vestibular vertigo, Meniere's disease, labyrinthitis) - this is the primary, well-established indication supported by clinical trial evidence.
• Nausea and vomiting of vestibular origin associated with vertigo, as an accompanying symptom of the vestibular disorder being treated.

Some formulations and clinical practice also use Artigo for prevention and relief of motion sickness, although this is a less formally evaluated, adjunct/off-label use in several regulatory labels compared with the vertigo indication; patients should follow their physician's specific advice for this use.

Artigo is indicated for adults; safety and efficacy in children and adolescents under 18 years have not been established.

Each tablet of Cinnarizine + Dimenhydrinate typically contains Cinnarizine 20 mg and Dimenhydrinate 40 mg as the active ingredients.

Artigo is a combination medicine used to treat vertigo (a spinning sensation of dizziness) and the nausea/vomiting that often accompanies it. It combines two complementary agents that act on the vestibular (balance) system: cinnarizine, a piperazine-derivative calcium channel blocker with antihistamine properties, and dimenhydrinate, an antihistamine with antiemetic and anticholinergic activity. Together they reduce the excitability of the vestibular apparatus and suppress the vomiting reflex triggered by vestibular disturbance.

Artigo is taken orally, generally after meals, and is intended for short-term, symptom-directed use rather than indefinite long-term therapy.

Artigo belongs to the therapeutic class of antivertigo agents / antihistamines used for vestibular disorders. Cinnarizine is classified as a piperazine-derivative calcium channel blocker with H1-antihistaminic activity, and dimenhydrinate is an ethanolamine-derivative H1-antihistamine with antiemetic and anticholinergic properties.

Cinnarizine + Dimenhydrinate combines two agents with complementary and synergistic actions on the vestibular system:

• Cinnarizine is a selective antagonist of T-type voltage-operated calcium channels and also has H1-antihistaminic, antiserotonergic, and weak antidopaminergic activity. At therapeutic concentrations it primarily reduces the excitability of vestibular hair cells and inhibits vestibular nystagmus, decreasing the frequency and intensity of vertigo attacks.
• Dimenhydrinate is an H1-receptor antagonist with central anticholinergic and antiemetic activity. It suppresses vestibular stimulation of the chemoreceptor trigger zone and vomiting centre, reducing nausea and vomiting of vestibular/motion origin.

The combination in Cinnarizine + Dimenhydrinate is designed to provide more complete relief of both the vertiginous sensation and its associated autonomic symptoms than either component alone. After oral administration, peak plasma concentrations of cinnarizine are reached in 1-3 hours; both components are hepatically metabolized and renally/faecally eliminated.

Artigo tablets should be swallowed whole (unchewed) with a sufficient amount of liquid, taken after meals to minimize gastric irritation. Do not take on an empty stomach.

Artigo has the following clinically significant interactions:

• CNS depressants (alcohol, barbiturates, opioids/narcotics, sedatives, tranquilizers): additive sedation and CNS depression when combined with Artigo; concurrent use should be avoided or undertaken with caution.
• Monoamine oxidase inhibitors (MAOIs): may potentiate the anticholinergic and sedative effects of Artigo.
• Other anticholinergic or antihypertensive drugs: Artigo may enhance their anticholinergic or blood-pressure-lowering effects.
• QT-prolonging drugs (e.g., Class Ia and III antiarrhythmics): concomitant use with Artigo should be avoided due to a theoretical additive risk of QT prolongation.
• Ototoxic drugs (e.g., aminoglycoside antibiotics): Artigo may mask early symptoms of ototoxicity (tinnitus, dizziness), delaying detection.
• Skin allergy (prick) tests: Artigo should be stopped several days before allergy skin testing as it can suppress cutaneous histamine responses and give false-negative results.
• CYP2D6 substrates: the diphenhydramine-related component of dimenhydrinate can inhibit CYP2D6; caution is warranted with drugs metabolized by this enzyme that have a narrow therapeutic index.

Artigo is generally well tolerated, but the following adverse effects have been reported:

• Common: Somnolence/drowsiness and fatigue (most frequent), dry mouth, headache, abdominal pain.
• Uncommon: Paraesthesia, memory disturbance (amnesia), tinnitus, tremor, nervousness, dyspepsia, nausea, diarrhoea, sweating, skin rash.
• Rare: Visual disturbances, photosensitivity, difficulty urinating (urinary hesitancy).
• Very rare: Blood disorders (leukopenia, thrombocytopenia, aplastic anaemia), hypersensitivity reactions, extrapyramidal symptoms, cholestatic jaundice, weight gain, paradoxical excitability (more common in children).

Patients should seek medical attention if severe or persistent side effects occur while taking Artigo.

Pregnancy: Artigo is not recommended during pregnancy. Data on use in pregnant women are limited, and animal reproduction studies are insufficient to establish safety. Artigo should be used in pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; a physician must be consulted before use.

Lactation: Both cinnarizine and dimenhydrinate are excreted into breast milk. Artigo should not be used during breast-feeding; if treatment is considered essential, a physician should advise on whether to interrupt breast-feeding.

Artigo should be used with caution in the following situations:

• Elderly patients: increased susceptibility to sedation and extrapyramidal (parkinsonism-like) symptoms with cinnarizine; use the lowest effective dose.
• Parkinson's disease: cinnarizine can worsen extrapyramidal symptoms; avoid in established disease (see Contraindications) and use with caution where suspected.
• Narrow-angle glaucoma, urinary retention, or prostatic hypertrophy (BPH): anticholinergic effects of dimenhydrinate may worsen these conditions.
• Hepatic or renal impairment: dose adjustment or avoidance may be needed; contraindicated in severe impairment (see Contraindications).
• Hypotension, severe coronary heart disease, or hyperthyroidism: use with caution due to anticholinergic and cardiovascular effects.
• Driving/operating machinery: Artigo commonly causes drowsiness and may impair alertness and reaction time; patients should not drive or operate hazardous machinery until they know how the medicine affects them.
• Alcohol and other CNS depressants: concurrent use should be avoided as sedative effects are additive (see Interactions).
• Duration of continuous use should generally not exceed 4 weeks without physician review.

Overdose with Artigo may cause drowsiness, dizziness, ataxia, and anticholinergic effects such as dry mouth, facial flushing, dilated pupils, rapid heartbeat, fever, headache, and urinary retention. Severe overdose may lead to convulsions, hallucinations, excitement, respiratory depression, hypertension, tremor, or coma, particularly in children.

If overdose of Artigo is suspected, seek immediate medical attention or contact a poison control centre/emergency services right away. Treatment is supportive and should be provided in a hospital setting; do not attempt specific home treatment.

Store Artigo at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Elderly: Use Artigo with caution; elderly patients are more susceptible to sedation and extrapyramidal symptoms. No formal dose reduction is established, but monitor closely.

Renal impairment: Use with caution in mild-to-moderate impairment; contraindicated in severe renal impairment (creatinine clearance ≤25 mL/min).

Hepatic impairment: Use with caution in mild-to-moderate impairment; contraindicated in severe hepatic impairment.

Pregnant and breastfeeding women: See Pregnancy and Lactation section.

Children under 18 years: Safety and efficacy of Artigo have not been established; not recommended.

Treatment with Artigo is generally intended for short-term, symptom-directed use. Continuous use should generally not exceed 4 weeks unless a physician determines that longer treatment is necessary and appropriate, with periodic reassessment of ongoing need.

Cinnarizine + Dimenhydrinate is classified as an antihistamine-based antivertigo/antiemetic combination: cinnarizine (piperazine-derivative calcium channel blocker with antihistaminic activity) plus dimenhydrinate (ethanolamine-derivative H1-antihistamine with anticholinergic and antiemetic activity).

Cinnarizine + Dimenhydrinate acts through two complementary mechanisms: cinnarizine reduces the excitability of vestibular hair cells and inhibits vestibular nystagmus via calcium channel and H1-receptor antagonism, while dimenhydrinate blocks H1 receptors and exerts central anticholinergic activity to suppress signals from the vestibular apparatus to the chemoreceptor trigger zone and vomiting centre, thereby reducing both vertigo and associated nausea/vomiting.

Artigo is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of Artigo in this population have not been established, and paediatric use may carry a higher risk of paradoxical excitability and anticholinergic adverse effects. Use in children should only occur under direct physician supervision if no suitable alternative exists.