Plaquverazon Side effects

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How do you administer this medicine?

What are the possible side effects of Plaquverazon?

Get emergency medical help if you have signs of an allergic reaction to Plaquverazon: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body. Tell your doctor if you have:

  • weight gain (especially in your face or your upper back and torso);

  • slow wound healing, thinning skin, increased body hair;

  • irregular menstrual periods, changes in sexual function; or

  • muscle weakness, tired feeling, depression, anxiety, feeling irritable.

Children can absorb larger amounts of this medicine through the skin and may be more likely to have side effects.

Stop using the medicine and call your doctor at once if you have:

  • severe burning or irritation where the medicine was applied;

  • redness or crusting around your hair follicles;

  • pus, swelling, redness, increased itching, or other signs of skin infection;

  • high levels of calcium in your blood - constipation, increased thirst or urination, muscle weakness, bone pain, confusion, lack of energy, or tired feeling; or

  • signs of low adrenal gland hormones - worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting, loss of appetite, diarrhea, and weight loss.

Common Plaquverazon side effects may include:

  • skin dryness, itching, burning, or irritation;

  • mild rash; or

  • changes in skin color.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Plaquverazon in details

infoA side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

The data described below reflect exposure to Plaquverazon® (calcipotriene and Betamethasone (Plaquverazon) dipropionate) Ointment in 2448 patients, including 1992 exposed for 4 weeks, and 289 exposed for 8 weeks. In the trials that included assessment of the effects of Plaquverazon® (calcipotriene and Betamethasone (Plaquverazon) dipropionate) Ointment on calcium metabolism, such testing was done after 4 weeks of treatment. The effects of Plaquverazon® (calcipotriene and Betamethasone (Plaquverazon) dipropionate) Ointment on calcium metabolism following treatment durations of longer than 4 weeks are not known. The effects of Plaquverazon® (calcipotriene and Betamethasone (Plaquverazon) dipropionate) Ointment on the HPA axis following treatment durations of longer than 4 weeks have not been adequately studied. Plaquverazon® (calcipotriene and Betamethasone (Plaquverazon) dipropionate) Ointment was studied primarily in placebo- and active-controlled trials (N = 1176, and N = 1272, respectively). The population was 15-97 years old, 61% males and 39% females, mostly white (97%) and had a baseline disease severity ranging from mild to very severe. Most patients received once daily application, and the median weekly dose was 24.5 g.

The percentage of subjects reporting at least one adverse event was 27.1% in the Plaquverazon® (calcipotriene and Betamethasone (Plaquverazon) dipropionate) Ointment group, 33.0% in the calcipotriene group, 28.3% in the Betamethasone (Plaquverazon) group, and 33.4% in the vehicle group.

Plaquverazon® (calcipotriene and Betamethasone (Plaquverazon) dipropionate)

Ointment

N=2448

Calcipotriene

N=3197

Betamethasone (Plaquverazon)

dipropionate

N=1164

Vehicle

N=470

Any Adverse Event 663 (27.1) 1055 (33.0) 329 (28.3) 157 (33.4)
Preferred Term # of subjects (%)
Pruritus 75 (3.1) 183 (5.7) 38 (3.3) 43 (9.1)
Headache 69 (2.8) 75 (2.3) 44 (3.8) 12 (2.6)
Nasopharyngitis 56 (2.3) 77 (2.4) 34 (2.9) 9 (1.9)
Psoriasis 30 (1.2) 47 (1.5) 14 (1.2) 5 (1.1)
Rash scaly 30 (1.2) 40 (1.3) 0 (0.0) 1 (0.2)
Influenza 23 (0.9) 34 (1.1) 14 (1.2) 6 (1.3)
Upper respiratory 20 (0.8) 19 (0.6) 12 (1.0) 3 (0.6)
tract infection 15 (0.6) 54 (1.7) 3 (0.3) 5 (1.1)
Erythema Application site 13 (0.5) 24 (0.8) 10 (0.9) 6 (1.3)
pruritus 11 (0.4) 60 (1.9) 8 (0.7) 5 (1.1)
Skin irritation 7 (0.3) 12 (0.4) 3 (0.3) 5 (1.1)
Pain Burning sensation 6 (0.2) 30 (0.9) 3 (0.3) 6 (1.3)

Adverse Events Reported by ≥ 1% of Subjects by Preferred Term

A lesional/perilesional adverse event was generally defined as an adverse event located ≤ 2 cm from the lesional border.

Lesional/Perilesional Adverse Events Reported by ≥ 1% of Subjects

Plaquverazon® (calcipotriene and Betamethasone (Plaquverazon) dipropionate)

Ointment

N=2448

Calcipotriene

N=3197

Betamethasone (Plaquverazon)

dipropionate

N=1164

Vehicle

N=470

Any Adverse Event 213 (8.7) 419 (13.1) 85 (7.3) 76 (16.2)
Preferred Term # of subjects (%)
Pruritus 69 (2.8) 170 (5.3) 31 (2.7) 41 (8.7)
Rash scaly 29 (1.2) 38 (1.2) 0 (0.0) 0 (0.0)
Application site pruritus 12 (0.5) 24 (0.8) 10 (0.9) 6 (1.3)
Erythema 9 (0.4) 36 (1.1) 2 (0.2) 4 (0.9)
Skin irritation 9 (0.4) 51 (1.6) 8 (0.7) 5 (1.1)
Burning sensation 6 (0.2) 25 (0.8) 3 (0.3) 5 (1.1)

For subjects who reported lesional/perilesional adverse events, the median time to onset was 7 days for Plaquverazon® (calcipotriene and Betamethasone (Plaquverazon) dipropionate) Ointment, 7 days for calcipotriene, 5 days for Betamethasone (Plaquverazon) dipropionate, and 3 days for vehicle.

Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of incidence, folliculitis, rash papular, rash pustular, and skin hypopigmentation. Skin atrophy, telangiectasia and skin hyperpigmentation were reported infrequently (0.1%).

In a separate study, patients (N=207) with at least moderate disease severity were given Plaquverazon® (calcipotriene and Betamethasone (Plaquverazon) dipropionate) Ointment intermittently on an “as needed” basis for up to 52 weeks. The median use was 15.4 g per week. The effects of Plaquverazon® (calcipotriene and Betamethasone (Plaquverazon) dipropionate) Ointment on calcium metabolism were not studied and the effects on the HPA axis were not adequately studied. The following adverse reactions were reported by 1% or more of the patients: pruritus (7.2%), psoriasis (3.4%), skin atrophy (1.9%), folliculitis (1.4%), burning sensation (1.4%), skin depigmentation (1.4%), ecchymosis (1.0%), erythema (1.0%) and hand dermatitis (1.0%). One case of a serious flare-up of psoriasis was reported.

Development of pustular psoriasis has been reported as an adverse reaction during and following use of Plaquverazon® (calcipotriene and Betamethasone (Plaquverazon) dipropionate) Ointment.

What is the most important information I should know about Plaquverazon?

Use Plaquverazon exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor.

Before using Plaquverazon, tell your doctor if you are pregnant or breast-feeding.

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

There may be other drugs that can affect Plaquverazon. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Stop using Plaquverazon and get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Plaquverazon contraindications

infoContraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Hypersensitivity to Calcipotriol (Plaquverazon) monohydrate or Betamethasone (Plaquverazon) dipropionate gel or to any of the excipients of Plaquverazon.

Due to the content of Calcipotriol (Plaquverazon), Plaquverazon gel is contraindicated in patients with known disorders of calcium metabolism.

Due to the content of corticosteroid, Plaquverazon gel is contraindicated in the following conditions: Viral (eg, herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wounds.

Plaquverazon gel is contraindicated in guttate, erythrodermic, exfoliative and pustular psoriasis. It is also contraindicated in patients with severe renal insufficiency or severe hepatic disorders.

References

  1. DailyMed. "CALCIPOTRIENE HYDRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DailyMed. "BETAMETHASONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "Betamethasone: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Plaquverazon are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Plaquverazon. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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